MAUDE Adverse Event Report: GENZYME BIOSURGERY (SEPRAMESH) SEPRAMESH IP; MCN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Edema (1820); Emotional Changes (1831); Headache (1880); Unspecified Infection (1930); Nausea (1970); Pain (1994); Scar Tissue (2060); Tachycardia (2095); Vomiting (2144); Dizziness (2194); Injury (2348); No Code Available (3191)

Event Type  Injury  

Event Description

Abdominal abscess [abdominal abscess] ([manufacturing production issue], [device ineffective], [product design issue], [purulent discharge]).Enterocutaneous fistula [enterocutaneous fistula].Infected sepramesh [device related infection].Encapsulated by very dense scar tissue/scarification [implant site scar].Severe wound complications [wound complication].Significant mental and physical pain and suffering/emotional distress [emotional suffering].Physical pain/increased chronic and debilitating pain [pain].Sustained permanent injury [permanent injury].Substantial physical deformity [acquired deformity nos].Case narrative: initial information received on 11-mar-2020 from united states regarding an unsolicited valid serious case received from a patient via lawyer.This case involves an unknown age patient who experienced abdominal abscess, enterocutaneous fistula, infected sepramesh, encapsulated by very dense scar tissue/scarification, severe wound complications, significant mental and physical pain and suffering/emotional distress, increased chronic and debilitating pain/physical pain, sustained permanent injury, substantial physical deformity, (latency unknown for all events), with the use of medical device carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (sepramesh ip).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2006, the patient implanted with a 20 cm x 30 cm carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate) (with an unknown batch number) for ventral hernia repair.It was reported that the physicians used and implanted the sepramesh and did not misuse, or alter the sepramesh in an unforeseeable manner.On an unknown date, after unknown latency, following carboxymethylcellulose, polyglycolic acid, polypropylene and sodium hyaluronate, the patient experienced abdominal abscess and on (b)(6) 2017 underwent surgery to address it.This event was assessed as medically significant.During the procedure, the surgeons observed that the infected carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate was only partially incorporated with the abdominal wall and was encapsulated by very dense scar tissue and pus.Due to the dense scarification, the surgeons were forced to leave a portion of the failed carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate in patient's abdomen.Following this procedure, on an unknown date, the patient developed enterocutaneous fistula and severe wound complications and had be placed on total parenteral nutrition via an implanted port.This event of enterocutaneous fistula was assessed as medically significant.On an unknown date, the patient experienced significant mental and physical pain and suffering, had sustained permanent injury, permanent and substantial physical deformity, had undergone corrective surgery and reportedly would be undergoing corrective surgery or surgeries.It was reported that the mesh was defective in its design, defective in its manufacture and construction.Although carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate design was used to prevent or minimize hernia recurrence and chronic pain, the design did not do so.Instead, the design increased the intense inflammatory and chronic foreign body response, which resulted in mesh contracture, mesh deformation, mesh migration, granulomatous and/or fibrotic tissue, increased foreign body sensation, increased chronic and debilitating pain, and infection.The defective and unreasonably dangerous condition of the carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate was the proximate cause of the damages and injuries complained by the patient.Action taken- not applicable for all events.Corrective treatment: surgery, total parenteral nutrition, implanted port for abdominal abcess; not reported for rest of the events.The patient outcome is reported unknown for all the events.

Event Description

Colitis [colitis] ([nausea], [vomiting], [tachycardia], [abdominal pain], [radiating pain]) pancytopenia [pancytopenia] inability to walk on her right foot [unable to walk] decreased mobility [mobility decreased] contraction in right foot [contracture of lower leg joint] abdominal abscess [abdominal abscess] ([device ineffective], [purulent discharge], [manufacturing production issue], [product design issue]) enterocutaneous fistula [enterocutaneous fistula] infected sepramesh [device related infection] encapsulated by very dense scar tissue/scarification [implant site scar] severe wound complications [wound complication] significant mental and physical pain and suffering/emotional distress [emotional suffering] physical pain/increased chronic and debilitating pain [pain] headache [headache] sustained permanent injury [permanent injury] substantial physical deformity [acquired deformity nos] mild dizziness after gait [dizziness] edema noted to iv site [injection site oedema] pain to right thumb [pain in thumb] case narrative: initial information received on 11-mar-2020 from united states regarding an unsolicited valid serious case from a patient via lawyer.This case involves 20 years old female patient who experienced abdominal abscess, enterocutaneous fistula, infected sepramesh, encapsulated by very dense scar tissue/scarification, severe wound complications, significant mental and physical pain and suffering/emotional distress, physical pain/increased chronic and debilitating pain, sustained permanent injury, substantial physical deformity, contracture in right foot, decreased mobility, mild dizziness after gait, colitis, pancytopenia, edema noted to iv site, headache, pain to right thumb and inability to walk on her right foot with the use of medical device carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (sepramesh ip).The patient's past medical history included pancreatic mass in 2005 with (benign mass solid pseudopapillary tumor), pancreaticoduodenectomy in (b)(6) 2006, pain (with pain has been 9/10 for 3 days- (b)(6) 2006) mobility decreased (secondary to pain, goal is to try walking when pain reduces), malnutrition, abdominal pain upper with right upper quadrant pain, pruritus, drug abuse, abdominal mass (with fluoroscopy interpretation on (b)(6) 2006, diagnostic read of abdomen-(b)(6) 2006 and (b)(6) 2006), musculoskeletal disorder with (r>l transfer of tendons), depression, staphylococcal sepsis, rectal haemorrhage (with admitted on (b)(6) 2006, discharged on (b)(6) 2006, single episode of brbpr (bright red blood per rectum)), coagulopathy (with admitted on (b)(6) 2006, discharged on (b)(6) 2006, urinary tract infection with with personal nerve palsy t-tube placed on (b)(6) 2006), portal vein thrombosis (with portal vein revascularization) and tobacco user.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing abdominal pain (with status post pancreatic mass removal, not relieved by morphine, sharp pain and review of systems included fever, chills , nausea, vomiting and diarrhea, dialudid for it), pancreatic carcinoma (with large mass of pancreas with atrophic body and tail endoscopic ultrasound was performed, pancreatic cancer for which portal vein resection, reconstruction, exploratory laparotomy performed), allergy to plastic tape, drug hypersensitivity, sepsis with (admitted on (b)(6) 2006, then readmitted on 18-nov-2006 as pat having fever, abdominal pain, biliary and gastric drain, positive culture for mrsa (methicillin resistant staphylococcus aureus) readmitted on (b)(6) 2007), cholangitis (with admitted on (b)(6) 2006, again admitted on (b)(6) 2007 )and menstrual disorder (with anemia likely as blood loss increased).Patient had talipes (right varus foot deformity/bilateral foot contractions in both feet (right foot equinovarus deformity and left foot equinus contracture).On (b)(6) 2007, patient was admitted for bilateral foot contractions in both feet (right >left) (right foot equinovarus deformity and left foot equinus contracture) during extended stay in icu (intensive care unit) for which procedure was performed (foot achilles compactors and ankle capsulotomy) and post operatively, cast to be placed for 4 weeks.Concomitant medications included hydromorphone hydrochloride (dilaudid) for pain and abdominal pain; morphine (morphine) for pain; paracetamol (tylenol); dextrose (dextrose); insulin human (novolin r) for blood glucose; promethazine (phenergan) for nausea or vomiting; clindamycin (clindamycin); enoxaparin sodium (lovenox); famotidine (pepcid); amino acids nos, carbohydrates nos, minerals nos, vitamins nos (tpn) famotidine (famotidine); sodium ferric gluconate complex (sodium ferric gluconate complex); sodium chloride (sodium chloride); epoetin alfa (epogen); magnesium sulfate (magnesium sulphate [magnesium sulfate]); vitamin k; potassium chloride (potassium chloride); piperacillin sodium, tazobactam sodium (zosyn); fentanyl (fentanyl); norepinephrine bitartrate (levophed); ondansetron (zofran) for nausea or vomiting; calcium chloride dihydrate, potassium chloride, sodium chloride, sodium lactate (lactated ringers); naloxone hydrochloride (narcan); linezolid (linezolid); gentamycin (gentamycin); sennoside a+b (senokot); ibuprofen (motrin) methadone (methadone); metronidazole (flagyl) fluconazole (diflucan); docusate sodium (colace); lorazepam (ativan); caspofungin (caspofungin); ketorolac tromethamine (toradol); methocarbamol (robaxin); temazepam (restoril) for insomnia; calcium carbonate (maalox) for dyspepsia; nutrients nos (peptamen); heparin (heparin); haloperidol (haldol; acetylsalicylic acid (aspirin); salicylic acid (eucerin) and bacitracin (bacitracin) on (b)(6) 2006, the patient implanted with a 20 cm x 30 cm carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (with an unknown batch number) for ventral hernia repair.It was reported that the physicians used and implanted the sepramesh and did not misuse or alter the sepramesh in an unforeseeable manner.Patient was using wheelchair for her decreased mobility secondary to her inability to walk on her right foot (gait inability) (onset and latency unknown).On an unknown date, after unknown latency patient presented with right upper quadrant abdominal pain radiating to back, pain was 8/10 felt like cramps, medicated with dilaudid for which patient was admitted on (b)(6) 2007 and ct scan (computerized tomography) showed inflammation of ascending colon for which patient was given intravenous fluids, started on flagyl and pain was managed.On (b)(6) 2007, again abdomen ct showed inflammation of transverse and descending colon and.Abdominal pain was improved later and had regular diet.Patient was also pan cytopenic during admission, but complete blood count was improving.Follow up to be done for biopsies, stool and cbc analysis.Patient also had nausea, vomiting but denied diarrhea and constipation.On (b)(6) 2007, patient was alert and had no complaints of abdominal pain.On (b)(6) 2007, edema noted at iv site (localized edema) and pain to right thumb (pain in extremity) (latency 10 months 30 days) cannula intact and encouraged to elevate hand on pillow.On (b)(6) 2007 medicated with tylenol for headache (onset and latency unknown) if any and dilaudid for abdominal pain with which pain improved to 3/10.Colonoscopy done on (b)(6) 2007 which showed no ulcer and pancytopenia was improving.Assessment and plan included also included: pancreatitis vs hepatitis and anemia improved.On (b)(6) 2007, patient again had a colonoscopy which showed benign colon mucosa and antibiotics used for it.Still having abdominal pain radiated to back (8/10).On an unknown date, after unknown latency, patient had decreased mobility for which gait analysis was performed and patient was issued crutches on (b)(6) 2008, also patient experienced mild dizziness after this.Patient developed contraction in right foot (joint contracture) after prolonged bed rest from her abdominal surgery (onset and latency unknown) for which patient undergone right foot triple arthrodesis procedure with possible bone allograft versus bone autograft from right versus left, got hospitalized for the same on (b)(6) 2008, pain was 8/10 but appeared calm, alert, aware, foot intact but crying for pain, on morphine.On (b)(6) 2008, patient denied pain now however wanted to have intravenous pain medicine and then pain was controlled after using iv antibiotics.Patient passed physical therapy on (b)(6) 2008, standing with crutches and got discharged the same day.Follow up in orthopedic clinic in 2 weeks.Assessment included to start on intravenous fluids.On (b)(6) 2008, patient was ready to walk, mobility improved, alert, vital signs stable, medicated with dilaudid, tolerated well.On an unknown date, after unknown latency, following carboxymethylcellulose, polyglycolic acid, polypropylene and sodium hyaluronate, the patient experienced abdominal abscess and on (b)(6) 2017 underwent surgery to address it.This event was assessed as medically significant.During the procedure, the surgeons observed that the infected carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (device related infection) was only partially incorporated with the abdominal wall and was encapsulated by very dense scar tissue (implant site scar) and pus (purulent discharge).Due to the dense scarification, the surgeons were forced to leave a portion of the failed carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate in patient's abdomen.Following this procedure, on an unknown date, the patient developed enterocutaneous fistula and severe wound complications and had be placed on total parenteral nutrition via an implanted port.This event of enterocutaneous fistula was assessed as medically significant.On an unknown date, the patient experienced significant mental and physical pain and suffering (emotional distress), had sustained permanent injury, permanent and substantial physical deformity, had undergone corrective surgery and reportedly would be undergoing corrective surgery or surgeries.It was reported that the mesh was defective in its design (product design issue), defective in its manufacture and construction (manufacturing production issue).Although carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate design was used to prevent or minimize hernia recurrence and chronic pain, the design did not do so (device ineffective).Instead, the design increased the intense inflammatory and chronic foreign body response, which resulted in mesh contracture, mesh deformation, mesh migration, granulomatous and/or fibrotic tissue, increased foreign body sensation, increased chronic and debilitating pain, and infection.The defective and unreasonably dangerous condition of the carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate was the proximate cause of the damages and injuries complained by the patient.Relevant laboratory test results included: colonoscopy - on (b)(6) 2007: [showed no ulcer]; computerized tomogram - on (b)(6) 2007: [inflammation of ascending colon, fatty infiltration of liver, pancreas atrophic, kidneys are unremarkable, no annormality in pelvis]; on (b)(6) 2007: [inflammation of transverse and descending colon]; lymphocyte count (1.2 - 3.2 10*9/l) - on (b)(6) 2007: 0.3 10*9/l [low]; lymphocyte percentage (17 - 48 %) - on (b)(6) 2007: 6.5 % [low]; monocyte count (0.3 - 0.8 10*9/l) - on (b)(6) 2007: 0 10*9/l [low]; monocyte percentage (4 - 10 %) - on (b)(6) 2007: 1.8 % [low]; red blood cell count (3.3 - 5.6 10*12/l) - on (b)(6) 2007: 3.2 10*12/l [low]; on (b)(6) 2007: 3.04 10*12/l [low]; on (b)(6) 2007: 3.06 10*12/l [low]; on (b)(6) 2007: 3.09 10*12/l; rle exam (right lower extremity) - on (b)(6) 2008: [slc elevated 3 pillows, n/v/m grossly intact r toes]; white blood cell count (4.3 - 11.3 10*9/l) - on (b)(6) 2007: 3.5 10*9/l [low]; on (b)(6) 2007: 2.5 10*9/l [low]; on (b)(6) 2007: 2.3 10*9/l [low]; on (b)(6) 2007: 3.1 10*9/l [low] action taken- not applicable for all events corrective treatment: surgery, total parenteral nutrition, implanted port for abdominal abscess; colonoscopy, ct (computerized tomography) pelvis and abdomen, ivf(intravenous fluids) for colitis and pan cytopenia; right foot triple arthrodesis for contraction in right foot; tylenol for headache; diladaud for abdominal pain, wheelchair for inability to walk on her right foot; crutches issued to patient, gait training for mobility decreased; not reported for rest of the events the patient outcome is reported unknown for all the events additional information was received on (b)(6) 2020 from non-healthcare professional.Patient demographics were added.Text amended accordingly.Additional information received on (b)(6) 2020 from lawyer.Hospital discharge summary processed.Medical history, concurrent conditions, concomitant medications added.Labs added.Events of contracture in right foot, decreased mobility, mild dizziness after gait, colitis, pancytopenia, edema noted to iv site, pain to right thumb and inability to walk on her right foot added.Clinical course updated and text amended accordingly.

Event Description

Findings of congestive failure [congestive cardiac failure].Moderate pulmonary edema [pulmonary edema].Gastric varix [gastric varices].Foreign body appeared to be a long plastic stent in stomach/gastric pouch [foreign body in stomach].Threw up bloody vomiting [vomiting blood].Pancytopenia [pancytopenia].Contraction in right foot [contracture of lower leg joint].Decreased mobility [mobility decreased].Inability to walk on her right foot [unable to walk].Moderate ascites [ascites].Colitis / c.Diff colitis [clostridium difficile colitis], ([nausea], [vomiting], [abdominal tenderness], [tachycardia], [chronic abdominal pain], [abdominal distension], [fever], [diarrhea], [radiating pain]).Abdominal abscess [abdominal abscess], ([device ineffective], [purulent discharge], [manufacturing production issue], [product design issue], [serous discharge]).Enterocutaneous fistula [enterocutaneous fistula].Infected sepramesh [device related infection].Encapsulated by very dense scar tissue / scarification [implant site scar].Severe wound complications [wound complication], ([culture wound positive], [enterococcus test positive], [pseudomonas aeruginosa test positive]).Significant mental and physical pain and suffering / emotional distress [emotional suffering].Physical pain/increased chronic and debilitating pain [pain].Headache [headache].Sustained permanent injury [permanent injury].Substantial physical deformity [acquired deformity nos].Mild dizziness after gait [dizziness].Small pleural effusion [pleural effusion].Edema noted to iv site [injection site oedema].Pain to right thumb [pain in thumb].Still hypotensive [hypotensive].Back pain [back pain].Appetite poor [appetite decreased nos] ([weight loss]).Joint pain / knee pain with walking [joint pain] ([pain upon movement]).Pedal edema [pedal edema].Nasal discharge [nasal discharge].Cough [cough].Skin warm and dry to touch [skin warm].Feeling anxious [feeling anxious].Can't sleep [difficulty sleeping].Poor physical health [general physical health deterioration].Skin warm and dry to touch [skin dry].(l) chest wall pain non radiating to arm [chest wall pain].Trace esophageal varices / single grade ii varix [esophageal varices].Burning urination [burning micturition].Constipation [constipation].Ingrow toe nail with pus [ingrown toe nail], ([erythema], [purulent discharge], [edema]) mild bilateral atelectasis or infiltrate / moderate atelectasis [atelectasis].Positive blood culture candida glabrata [blood culture positive] ([candida test positive]).Case narrative: initial information received on 11-mar-2020 from united states regarding a legal unsolicited valid serious case from a patient via lawyer.This case involves 20 years old female patient (157.4 cm) who experienced colitis / c.Diff colitis, pancytopenia, inability to walk on her right foot, decreased mobility, contraction in right foot, abdominal abscess, abdominal discharge, enterocutaneous fistula, infected sepramesh, encapsulated by very dense scar tissue / scarification, severe wound complications, significant mental and physical pain and suffering / emotional distress, physical pain / increased chronic and debilitating pain, headache, sustained permanent injury, substantial physical deformity, mild dizziness after gait, edema noted to iv site, pain to right thumb, still hypotensive, back pain, appetite poor, joint pain / knee pain with walking, pedal edema, nasal discharge, cough, skin warm and dry to touch, feeling anxious, can't sleep, poor physical health, skin warm and dry to touch, threw up bloody vomiting, (l) chest wall pain non radiating to arm, foreign body appeared to be a long plastic stent in stomach / gastric pouch, trace esophageal varices / single grade ii varix, gastric varix, burning urination, constipation, ingrow toe nail with pus, moderate pulmonary edema, findings of congestive failure, mild bilateral atelectasis or infiltrate and positive blood culture candida glabrata, moderate ascites, small pleural effusion with the use of medical device carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (sepramesh ip).Past medical history included pancreatic mass in 2005 with (benign mass solid pseudopapillary tumor) and had whipple on (b)(6) 2006 for it, pain (has been 9/10 for 3 days- on (b)(6) 2006), mobility decreased (secondary to pain, goal was to try walking when pain reduces), malnutrition, ruq epigastric right upper quadrant pain, local itching over abdomen, amphetamine and marijuana positive social history, large abdominal mass (fluoroscopy interpretation on (b)(6) 2006, diagnostic read of abdomen on (b)(6) 2006), ble (bilateral lower extremity) contraction (r>l transfer of tendons), depression, sepsis mrsa, blood per rectum (admitted on (b)(6) 2006, discharged on (b)(6) 2006, bright red blood per rectum, episodic and intermittent colonoscopy on (b)(6) 2012), coagulopathy (with admitted on (b)(6) 2006, discharged on (b)(6) 2006, urinary tract infection with personal nerve palsy t-tube placed on (b)(6) 2006), portal vein thrombosis (portal vein revascularization), multiple surgeries, occupational therapy, midline abdominal wound, acute rehab, gastrostomy and jejunostomy tube, abdominal skin graft, leukocytosis, picc line placement, right ankle contracture, constipation, pain over lat aspect (r) anke and (r) heel, decreased rom, abnormal gait pattern, pancreatic insufficiency, decreased balance, splenomegaly, mild/moderate gastroparesis, rue thrombosis, gastritis, gastric bypass, kidney infection, gastric outlet stenosis, difficulty breathing (placed on bipap, need for o2), sinus tachycardia, anemia and occasional alcohol and tobacco user.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing osteopenia, altered tissue perfusion, portal hypertension, pancreatic cancer / pseudopapillary tumor (pancreas) stage ib, abdominal pain (status post pancreatic mass removal, not relieved by morphine, sharp pain and review of systems included fever, chills , nausea, vomiting and diarrhea, dialudid for it), malignant neoplasm of head of pancreas (with large mass of pancreas with atrophic body and tail endoscopic ultrasound performed, pancreatic cancer for which portal vein resection, reconstruction, exploratory laparotomy performed), allergy to plastic tape, allergy to vancomycin and fentanyl / morphine, reglan, phenergan (rash with morphine and reglan), sepsis (admitted on (b)(6) 2006, then readmitted on (b)(6) 2006 as (b)(6) having fever, abdominal pain, biliary and gastric drain, positive culture for mrsa (methicillin resistant staphylococcus aureus) readmitted on (b)(6) 2007), ascending cholangitis (admitted on (b)(6) 2006, again on (b)(6) 2007 )and abnormal periods since whipple (anemia likely as blood loss increased).Patient had right varus foot deformity / bilateral foot contractions in both feet (right foot equinovarus deformity and left foot equinus contracture).On (b)(6) 2007, patient was admitted for bilateral foot contractions in both feet (right >left) (right foot equinovarus deformity and left foot equinus contracture) during extended stay in icu (intensive care unit) for which procedure was performed (foot achilles compactors and ankle capsulotomy) and post operatively, cast to be placed for 4 weeks.Concomitant medications included hydromorphone hydrochloride (dilaudid) for pain and abdominal pain; morphine for pain; paracetamol (tylenol); dextrose (dextrose); insulin human (novolin r) for blood glucose; promethazine (phenergan) for nausea or vomiting; clindamycin; enoxaparin sodium (lovenox); famotidine (pepcid); amino acids nos, carbohydrates nos, minerals nos, vitamins nos (tpn) famotidine; sodium ferric gluconate complex; sodium chloride; epoetin alfa (epogen); magnesium sulfate; vitamin k; potassium chloride; piperacillin sodium, tazobactam sodium (zosyn); fentanyl; norepinephrine bitartrate (levophed); ondansetron (zofran) for nausea or vomiting; calcium chloride dihydrate, potassium chloride, sodium chloride, sodium lactate (lactated ringers); naloxone hydrochloride (narcan); linezolid (linezolid); gentamycin (gentamycin); sennoside a+b (senokot); ibuprofen (motrin) methadone (methadone); metronidazole (flagyl) fluconazole (diflucan); docusate sodium (colace); lorazepam (ativan); caspofungin (caspofungin); ketorolac tromethamine (toradol); methocarbamol (robaxin); temazepam (restoril) for insomnia; calcium carbonate (maalox) for dyspepsia; nutrients nos (peptamen); heparin; haloperidol (haldol); acetylsalicylic acid (aspirin); salicylic acid (eucerin) and bacitracin.On (b)(6) 2006, patient was implanted with a 20 cm x 30 cm carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (unknown (unk) batch number) for ventral hernia repair.It was reported that physicians used and implanted sepramesh and did not misuse or alter the sepramesh in an unforeseeable manner.Same day, wound culture was positive 2+ enterococcus faecium.On (b)(6) 2006, patient was still hypotensive (onset, latency, unk).On (b)(6) 2006, patient had nausea and abdominal computed tomography (ct) showed new bilateral small pleural effusion, moderate atelectasis, moderate ascites (medically significant), umbilical hernia in mid lowed abdomen (latency: 2 days).On (b)(6) 2006, in pain, had nausea, very distended abdomen, tender and fever, chest radiograph had impression of infiltrates in mid and lower lungs with small pleural effusion.On (b)(6) 2006, chest ra showed moderate pulmonary edema (latency: 4 days, medically significant) and on (b)(6) 2006 had impression of likely diffuse pneumonia versus edema.On (b)(6) 2006, ra chest showed finding of congestive failure (cardiac failure congestive; latency: 6 days, medically significant).On (b)(6) 2006, ra chest showed mild bilateral atelectasis or infiltrates, borderline cardiac size.On (b)(6) 2006, ra chest showed bilateral basilar infiltrates.On (b)(6) 2007, positive blood culture showed candida glabrata, wound culture 4+ pseudomonas aeruginosa (latency: 14 days).On (b)(6) 2007, ra chest showed heart not enlarged, impression of basilar atelectasis especially left lower lobe, on (b)(6) 2007, showed progressive infiltrate / atelectasis at lung bases, on (b)(6) 2007: low lung volume, volume overload and on (b)(6) 2007: moderate to severe edema.Patient was using wheelchair for her decreased mobility secondary to her inability to walk on her right foot (gait inability) (disability; onset and latency unk).On (b)(6) 2007, patient was noted to have ingrown toe nail with pus (ingrowing nail), toe cuticle erythema, edema, purulent discharge (onset, latency: unk).On an unk date, unk latency patient presented with right upper quadrant abdominal pain radiating to back, pain was 8/10 felt like cramps, medicated with hydromorphone hydrochloride for which patient was admitted on (b)(6) 2007 and ct scan (computerized tomography) showed inflammation of ascending colon for which patient was given intravenous fluids, started on metronidazole and pain was managed.On (b)(6) 2007, again abdomen ct showed inflammation of transverse and descending colon and.Abdominal pain was improved later and had regular diet.Patient was also pan cytopenic during admission (hospitalization, intervention required), but complete blood count was improving.Follow up to be done for biopsies, stool and cbc analysis.Patient also had nausea, vomiting but denied diarrhea and constipation.On an unk date, unk latency, patient had c.Diff colitis (clostridium difficile colitis; medically significant, required intervention, hospitalization).On (b)(6) 2007, patient was alert and had no complaints of abdominal pain.On (b)(6) 2007, edema noted at iv site (localized edema) and pain to right thumb (pain in extremity) (latency 10 months 30 days) cannula intact and encouraged to elevate hand on pillow.On (b)(6) 2007 medicated with paracetamol for headache (onset and latency unk) if any and hydromorphone hydrochloride for abdominal pain with which pain improved to 3/10.Colonoscopy done on (b)(6) 2007 which showed no ulcer and pancytopenia was improving.Assessment and plan included also included: pancreatitis vs hepatitis and anemia improved.On (b)(6) 2007, patient again had a colonoscopy which showed benign colon mucosa and antibiotics used for it.Still having abdominal pain radiated to back (8/10).On an unk date, unk latency, patient had decreased mobility for which gait analysis was performed and patient was issued crutches on (b)(6) 2008, also patient experienced mild dizziness after this.Patient developed contraction in right foot (joint contracture) after prolonged bed rest from her abdominal surgery (onset and latency unk) for which patient undergone right foot triple arthrodesis procedure with possible bone allograft versus bone autograft from right versus left, got hospitalized for the same on (b)(6) 2008, pain was 8/10 but appeared calm, alert, aware, foot intact but crying for pain, on morphine.On (b)(6) 2008, patient denied pain now however wanted to have intravenous pain medicine and then pain was controlled after using iv antibiotics.Patient passed physical therapy on (b)(6) 2008, standing with crutches and got discharged the same day.Follow up in orthopedic clinic in 2 weeks.Assessment included to start on intravenous fluids.On (b)(6) 2008, patient was ready to walk, mobility improved, alert, vital signs stable, medicated with hydromorphone hydrochloride, tolerated well.On an unk date, unk latency, the patient experienced abdominal abscess (medically significant, required intervention) having serosanguinous fluid, blood coloured drainage, yellowish green secretions and on (b)(6) 2017 underwent surgery to address it.During the procedure, the surgeons observed that the infected carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (device related infection) was only partially incorporated with the abdominal wall and was encapsulated by very dense scar tissue (implant site scar) and pus (purulent discharge).Due to the dense scarification, the surgeons were forced to leave a portion of the failed carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate in patient's abdomen.Following this procedure, on an unk date, the patient developed enterocutaneous fistula (medically significant) and severe wound complications and had be placed on total parenteral nutrition via an implanted port.On an unk date, the patient experienced significant mental and physical pain and suffering (emotional distress), had sustained permanent injury, permanent and substantial physical deformity, had undergone corrective surgery and reportedly would be undergoing corrective surgery or surgeries.It was reported that the mesh was defective in its design (product design issue), defective in its manufacture and construction (manufacturing production issue).Although its design was used to prevent or minimize hernia recurrence and chronic pain, the design did not do so (device ineffective).Instead, the design increased the intense inflammatory and chronic foreign body response, which resulted in mesh contracture, mesh deformation, mesh migration, granulomatous and/or fibrotic tissue, increased foreign body sensation, increased chronic and debilitating pain, and infection.The defective and unreasonably dangerous condition of the device was the proximate cause of the damages and injuries complained by the patient.On (b)(6) 2010, noted to have knee pain intermittent with walking (onset, latency: unk).On (b)(6) 2010, impression of constipation, side flank pain, nausea, vomiting, edema, dry and warm skin (onset, latency: unk).On (b)(6) 2011, patient had impression of constipation, flank pain, nausea, vomiting, edema, dry and warm skin and there was no evidence of obstruction.On (b)(6) 2012, patient admitted to hospital for foreign body appeared to be a long plastic stent in stomach / gastric pouch (foreign body in gastrointestinal tract; required intervention), noted to have burning urination (dysuria), vomiting, nausea, abdominal pain sharp, constant, getting worse, radiating to back (onset, latency: unk).On (b)(6) 2012, due to abdominal pain esophagogastroduodenoscopy with foreign body removal with balloon dilation was done which showed gastritis, gastric outlet stenosis which was diluted, trace esophageal varices, gastric varix (medically significant) (onset, latency: unk).On (b)(6) 2012, had surgery due to vomiting showed esophageal single grade ii varix and esophagogastroduodenoscopy was done and patient was told to avoid opioids or other medications that can contribute to gastroparesis.On (b)(6) 2012, patient was discharged.On (b)(6) 2012, had back pain, fever, vomiting, nausea, abdominal pain, skin warm (onset, latency: unk).On (b)(6) 2012, noted to have weight loss, poor appetite (decreased appetite), nausea constipation, vomiting, and on (b)(6) 2012, pedal edema (oedema peripheral), distended abdomen, (onset, latency: unk) admitted for abdominal pain, given iv and oral antibiotics for possible colitis and patient discharged against medical advice same day.On unk date, unk latency, patient had cough and nasal discharge (rhinorrhoea).On (b)(6) 2012, mentioned feeling anxious (anxiety) and could not sleep (insomnia), weight loss, nausea / vomiting, abdominal and back pain, poor physical health (general physical health deterioration), skin warm and dry to touch, threw up blood vomiting (haematemesis; medically significant) (onset, latency: unk) and discharged cancelled.Patient also complained of (l) chest pain non radiating to arms (musculoskeletal chest pain; onset, latency: unk), no shortness of breath.Relevant laboratory test results included: colonoscopy: on (b)(6) 2007: [showed no ulcer]; computerized tomogram: on (b)(6) 2007: [inflammation of ascending colon, fatty infiltration of liver, pancreas atrophic, kidneys are unremarkable, no abnormality in pelvis]; on (b)(6) 2007: [inflammation of transverse and descending colon]; lymphocyte count (1.2 - 3.2 10*9/l) on (b)(6) 2007: 0.3 10*9/l [low]; lymphocyte percentage (17 - 48 %) on (b)(6) 2007: 6.5 % [low]; monocyte count (0.3 - 0.8 10*9/l) on (b)(6) 2007: 0 10*9/l [low]; monocyte percentage (4 - 10 %) on (b)(6) 2007: 1.8 % [low]; red blood cell count (3.3 - 5.6 10*12/l) on (b)(6) 2007: 3.2 10*12/l [low]; on (b)(6) 2007: 3.04 10*12/l [low]; on (b)(6) 2007: 3.06 10*12/l [low]; on (b)(6) 2007: 3.09 10*12/l; rle exam (right lower extremity) on (b)(6) 2008: [slc elevated 3 pillows, n/v/m grossly intact r toes]; white blood cell count (4.3 - 11.3 10*9/l) on (b)(6) 2007: 3.5 10*9/l [low]; on (b)(6) 2007: 2.5 10*9/l [low]; on (b)(6) 2007: 2.3 10*9/l [low]; on (b)(6) 2007: 3.1 10*9/l [low].Action taken- not applicable for all events.Corrective treatment: surgery, total parenteral nutrition, implanted port for abdominal abscess; colonoscopy, ct (computerized tomography) pelvis and abdomen, ivf(intravenous fluids), iv and oral antibiotics for colitis/ c.Diff colitis and pan cytopenia; right foot triple arthrodesis for contraction in right foot; tylenol for headache; diladaud for abdominal pain, wheelchair for inability to walk on her right foot; crutches issued to patient, gait training for mobility decreased; cleanse, sterile non adherent dressing, cefalosporin, cefalin (keflex), magnesium sulfate (epson salt) for ingrow toe nail with pus, surgical removal for foreign body appeared to be a long plastic stent in stomach / gastric pouch, hydrocodone bitartrate, paracetamol (norco) for (l) chest wall pain non radiating to arm, nsaids (non-steroidal anti-inflammatory drugs) and ibuprofen for joint pain/knee pain with walking, not reported for rest of the events.Outcome: recovered for skin warm and dry to touch, recovering for ruq abdominal pain radiating to back / pain is 8/10 in ruq feels like cramps / chronic abdominal pain / l sided radiates to r, nausea, very distended abdomen, tender abdomen, unk for rest of the events.A product technical complaint was initiated and results were pending for the same.Additional information received on 23-jul-2020 from non-healthcare professional.Patient demographics were added.Additional information received on 19-aug-2020 from lawyer.Hospital discharge summary processed.Medical history, concurrent conditions, concomitant medications added.Labs added.Events of contracture in right foot, decreased mobility, mild dizziness after gait, colitis, pancytopenia, edema noted to iv site, pain to right thumb and inability to walk on her right foot added.Additional information received on 24-aug-2020 from lawyer.Events of hypotensive, back pain, appetite poor, joint pain/knee pain with walking, pedal edema, nasal discharge, cough, skin warm and dry to touch, feeling anxious, can't sleep, poor physical health, skin warm and dry to touch, threw up bloody vomiting, (l) chest wall pain non radiating to arm, sob, foreign body appeared to be a long plastic stent in stomach / gastric pouch, trace esophageal varices / single grade ii varix, gastroc varix, burning urination, constipation, ingrow toe nail with pus, moderate pulmonary edema, findings of congestive failure, mild bilateral atelectasis or infiltrate and positive blood culture candida glabrata added.Medical history, concomitant medications, labs updated.On (b)(6) 2020, with clock start date of on (b)(6) 2020, significant amendment performed for case submission of last follow up version.

Event Description

Colitis [colitis] ([nausea], [vomiting], [tachycardia], [abdominal pain], [radiating pain]), pancytopenia [pancytopenia] , inability to walk on her right foot [unable to walk] , decreased mobility [mobility decreased], contraction in right foot [contracture of lower leg joint], abdominal abscess [abdominal abscess] ([device ineffective], [purulent discharge], [manufacturing production issue], [product design issue]), enterocutaneous fistula [enterocutaneous fistula], infected sepramesh [device related infection], encapsulated by very dense scar tissue/scarification [implant site scar], severe wound complications [wound complication], significant mental and physical pain and suffering/emotional distress [emotional suffering], physical pain/increased chronic and debilitating pain [pain], headache [headache], sustained permanent injury [permanent injury], substantial physical deformity [acquired deformity nos] , mild dizziness after gait [dizziness], edema noted to iv site [injection site oedema] , pain to right thumb [pain in thumb], case narrative: initial information received on 11-mar-2020 from united states regarding an unsolicited valid serious case from a patient via lawyer.This case involves 20 years old female patient who experienced abdominal abscess, enterocutaneous fistula, infected sepramesh, encapsulated by very dense scar tissue/scarification, severe wound complications, significant mental and physical pain and suffering/emotional distress, physical pain/increased chronic and debilitating pain, sustained permanent injury, substantial physical deformity, contracture in right foot, decreased mobility, mild dizziness after gait, colitis, pancytopenia, edema noted to iv site, headache, pain to right thumb and inability to walk on her right foot with the use of medical device carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (sepramesh ip).The patient's past medical history included pancreatic mass in 2005 with (benign mass solid pseudopapillary tumor), pancreaticoduodenectomy in (b)(6) 2006, pain (with pain has been 9/10 for 3 days- (b)(6) 2006), mobility decreased (secondary to pain, goal is to try walking when pain reduces), malnutrition, abdominal pain upper with right upper quadrant pain, pruritus, drug abuse, abdominal mass (with fluoroscopy interpretation on (b)(6) 2006, diagnostic read of abdomen- (b)(6) 2006), musculoskeletal disorder with (r>l transfer of tendons), depression, staphylococcal sepsis, rectal haemorrhage (with admitted on (b)(6) 2006, discharged on (b)(6) 2006, single episode of brbpr (bright red blood per rectum)), coagulopathy (with admitted on (b)(6) 2006, discharged on (b)(6) 2006, urinary tract infection with personal nerve palsy t-tube placed on (b)(6) 2006), portal vein thrombosis (with portal vein revascularization) and tobacco user.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing abdominal pain (with status post pancreatic mass removal, not relieved by morphine, sharp pain and review of systems included fever, chills , nausea, vomiting and diarrhea, dialudid for it), pancreatic carcinoma (with large mass of pancreas with atrophic body and tail endoscopic ultrasound was performed, pancreatic cancer for which portal vein resection, reconstruction, exploratory laparotomy performed), allergy to plastic tape, drug hypersensitivity, sepsis with (admitted on (b)(6) 2006, then readmitted on (b)(6) 2006 as pat having fever, abdominal pain, biliary and gastric drain, positive culture for mrsa (methicillin resistant staphylococcus aureus) readmitted on (b)(6) 2007), cholangitis (with admitted on (b)(6) 2006, again admitted on (b)(6) 2007 )and menstrual disorder (with anemia likely as blood loss increased).Patient had talipes (right varus foot deformity/bilateral foot contractions in both feet (right foot equinovarus deformity and left foot equinus contracture).On (b)(6) 2007, patient was admitted for bilateral foot contractions in both feet (right >left) (right foot equinovarus deformity and left foot equinus contracture) during extended stay in icu (intensive care unit) for which procedure was performed (foot achilles compactors and ankle capsulotomy) and post operatively, cast to be placed for 4 weeks.Concomitant medications included hydromorphone hydrochloride (dilaudid) for pain and abdominal pain; morphine (morphine) for pain; paracetamol (tylenol); dextrose (dextrose); insulin human (novolin r) for blood glucose; promethazine (phenergan) for nausea or vomiting; clindamycin (clindamycin); enoxaparin sodium (lovenox); famotidine (pepcid); amino acids nos, carbohydrates nos, minerals nos, vitamins nos (tpn) famotidine (famotidine); sodium ferric gluconate complex (sodium ferric gluconate complex); sodium chloride (sodium chloride); epoetin alfa (epogen); magnesium sulfate (magnesium sulphate [magnesium sulfate]); vitamin k; potassium chloride (potassium chloride); piperacillin sodium, tazobactam sodium (zosyn); fentanyl (fentanyl); norepinephrine bitartrate (levophed); ondansetron (zofran) for nausea or vomiting; calcium chloride dihydrate, potassium chloride, sodium chloride, sodium lactate (lactated ringers); naloxone hydrochloride (narcan); linezolid (linezolid); gentamycin (gentamycin); sennoside a+b (senokot); ibuprofen (motrin) methadone (methadone); metronidazole (flagyl) fluconazole (diflucan); docusate sodium (colace); lorazepam (ativan); caspofungin (caspofungin); ketorolac tromethamine (toradol); methocarbamol (robaxin); temazepam (restoril) for insomnia; calcium carbonate (maalox) for dyspepsia; nutrients nos (peptamen); heparin (heparin); haloperidol (haldol; acetylsalicylic acid (aspirin); salicylic acid (eucerin) and bacitracin (bacitracin) on (b)(6) 2006, the patient implanted with a 20 cm x 30 cm carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (with an unknown batch number) for ventral hernia repair.It was reported that the physicians used and implanted the sepramesh and did not misuse or alter the sepramesh in an unforeseeable manner.Patient was using wheelchair for her decreased mobility secondary to her inability to walk on her right foot (gait inability) (onset and latency unknown).On an unknown date, after unknown latency patient presented with right upper quadrant abdominal pain radiating to back, pain was 8/10 felt like cramps, medicated with dilaudid for which patient was admitted on (b)(6) 2007 and ct scan (computerized tomography) showed inflammation of ascending colon for which patient was given intravenous fluids, started on flagyl and pain was managed.On (b)(6) 2007, again abdomen ct showed inflammation of transverse and descending colon and.Abdominal pain was improved later and had regular diet.Patient was also pan cytopenic during admission, but complete blood count was improving.Follow up to be done for biopsies, stool and cbc analysis.Patient also had nausea, vomiting but denied diarrhea and constipation.On (b)(6) 2007, patient was alert and had no complaints of abdominal pain.On (b)(6) 2007, edema noted at iv site (localized edema) and pain to right thumb (pain in extremity) (latency 10 months 30 days) cannula intact and encouraged to elevate hand on pillow.On (b)(6) 2007 medicated with tylenol for headache (onset and latency unknown) if any and dilaudid for abdominal pain with which pain improved to 3/10.Colonoscopy done on (b)(6) 2007 which showed no ulcer and pancytopenia was improving.Assessment and plan included also included: pancreatitis vs hepatitis and anemia improved.On (b)(6) 2007, patient again had a colonoscopy which showed benign colon mucosa and antibiotics used for it.Still having abdominal pain radiated to back (8/10).On an unknown date, after unknown latency, patient had decreased mobility for which gait analysis was performed and patient was issued crutches on (b)(6) 2008, also patient experienced mild dizziness after this.Patient developed contraction in right foot (joint contracture) after prolonged bed rest from her abdominal surgery (onset and latency unknown) for which patient undergone right foot triple arthrodesis procedure with possible bone allograft versus bone autograft from right versus left, got hospitalized for the same on (b)(6) 2008, pain was 8/10 but appeared calm, alert, aware, foot intact but crying for pain, on morphine.On (b)(6) 2008, patient denied pain now however wanted to have intravenous pain medicine and then pain was controlled after using iv antibiotics.Patient passed physical therapy on (b)(6) 2008, standing with crutches and got discharged the same day.Follow up in orthopedic clinic in 2 weeks.Assessment included to start on intravenous fluids.On (b)(6) 2008, patient was ready to walk, mobility improved, alert, vital signs stable, medicated with dilaudid, tolerated well.On an unknown date, after unknown latency, following carboxymethylcellulose, polyglycolic acid, polypropylene and sodium hyaluronate, the patient experienced abdominal abscess and on (b)(6) 2017 underwent surgery to address it.This event was assessed as medically significant.During the procedure, the surgeons observed that the infected carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (device related infection) was only partially incorporated with the abdominal wall and was encapsulated by very dense scar tissue (implant site scar) and pus (purulent discharge).Due to the dense scarification, the surgeons were forced to leave a portion of the failed carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate in patient's abdomen.Following this procedure, on an unknown date, the patient developed enterocutaneous fistula and severe wound complications and had be placed on total parenteral nutrition via an implanted port.This event of enterocutaneous fistula was assessed as medically significant.On an unknown date, the patient experienced significant mental and physical pain and suffering (emotional distress), had sustained permanent injury, permanent and substantial physical deformity, had undergone corrective surgery and reportedly would be undergoing corrective surgery or surgeries.It was reported that the mesh was defective in its design (product design issue), defective in its manufacture and construction (manufacturing production issue).Although carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate design was used to prevent or minimize hernia recurrence and chronic pain, the design did not do so (device ineffective).Instead, the design increased the intense inflammatory and chronic foreign body response, which resulted in mesh contracture, mesh deformation, mesh migration, granulomatous and/or fibrotic tissue, increased foreign body sensation, increased chronic and debilitating pain, and infection.The defective and unreasonably dangerous condition of the carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate was the proximate cause of the damages and injuries complained by the patient.Relevant laboratory test results included: colonoscopy - on (b)(6) 2007: [showed no ulcer]; computerized tomogram - on (b)(6) 2007: [inflammation of ascending colon, fatty infiltration of liver, pancreas atrophic, kidneys are unremarkable, no annormality in pelvis]; on (b)(6) 2007: [inflammation of transverse and descending colon]; lymphocyte count (1.2 - 3.2 10*9/l) - on (b)(6) 2007: 0.3 10*9/l [low]; lymphocyte percentage (17 - 48 %) - on (b)(6) 2007: 6.5 % [low]; monocyte count (0.3 - 0.8 10*9/l) - on (b)(6) 2007: 0 10*9/l [low]; monocyte percentage (4 - 10 %) - on (b)(6) 2007: 1.8 % [low]; red blood cell count (3.3 - 5.6 10*12/l) - on (b)(6) 2007: 3.2 10*12/l [low]; on (b)(6) 2007: 3.04 10*12/l [low]; on (b)(6) 2007: 3.06 10*12/l [low]; on (b)(6) 2007: 3.09 10*12/l; rle exam (right lower extremity) - on (b)(6) 2008: [slc elevated 3 pillows, n/v/m grossly intact r toes]; white blood cell count (4.3 - 11.3 10*9/l) - on (b)(6) 2007: 3.5 10*9/l [low]; on (b)(6) 2007: 2.5 10*9/l [low]; on (b)(6) 2007: 2.3 10*9/l [low]; on (b)(6) 2007: 3.1 10*9/l [low].Action taken- not applicable for all events.Corrective treatment: surgery, total parenteral nutrition, implanted port for abdominal abscess; colonoscopy, ct (computerized tomography) pelvis and abdomen, ivf(intravenous fluids) for colitis and pan cytopenia; right foot triple arthrodesis for contraction in right foot; tylenol for headache; diladaud for abdominal pain, wheelchair for inability to walk on her right foot; crutches issued to patient, gait training for mobility decreased; not reported for rest of the events.The patient outcome is reported unknown for all the events.Additional information was received on 23-jul-2020 from non-healthcare professional.Patient demographics were added.Text amended accordingly.Additional information received on 19-aug-2020 from lawyer.Hospital discharge summary processed.Medical history, concurrent conditions, concomitant medications added.Labs added.Events of contracture in right foot, decreased mobility, mild dizziness after gait, colitis, pancytopenia, edema noted to iv site, pain to right thumb and inability to walk on her right foot added.Clinical course updated and text amended accordingly.

Event Description

Findings of congestive failure [congestive cardiac failure].Moderate pulmonary edema [pulmonary edema].Gastric varix [gastric varices].Foreign body appeared to be a long plastic stent in stomach/gastric pouch [foreign body in stomach].Threw up bloody vomiting [vomiting blood].Pancytopenia [pancytopenia].Contraction in right foot [contracture of lower leg joint].Decreased mobility [mobility decreased].Inability to walk on her right foot [unable to walk].Moderate ascites [ascites].Colitis/ c.Diff colitis [clostridium difficile colitis] ([nausea], [vomiting], [abdominal tenderness], [tachycardia], [chronic abdominal pain], [abdominal distension], [fever], [diarrhea], [radiating pain]).Abdominal abscess [abdominal abscess] ([device ineffective], [purulent discharge], [manufacturing production issue], [product design issue], [serous discharge]).Enterocutaneous fistula [enterocutaneous fistula].Infected sepramesh [device related infection].Encapsulated by very dense scar tissue/scarification [implant site scar].Severe wound complications [wound complication] ([culture wound positive].[enterococcus test positive], [pseudomonas aeruginosa test positive]).Significant mental and physical pain and suffering/emotional distress [emotional suffering].Physical pain/increased chronic and debilitating pain [pain].Headache [headache].Sustained permanent injury [permanent injury].Substantial physical deformity [acquired deformity nos].Mild dizziness after gait [dizziness].Small pleural effusion [pleural effusion].Edema noted to iv site [injection site oedema].Pain to right thumb [pain in thumb].Still hypotensive [hypotensive].Back pain [back pain].Appetite poor [appetite decreased nos] ([weight loss]).Joint pain/knee pain with walking [joint pain] ([pain upon movement]).Pedal edema [pedal edema].Nasal discharge [nasal discharge].Cough [cough].Skin warm and dry to touch [skin warm].Feeling anxious [feeling anxious].Can't sleep [difficulty sleeping].Poor physical health [general physical health deterioration].Skin warm and dry to touch [skin dry].(l) chest wall pain non radiating to arm [chest wall pain].Trace esophageal varices/single grade ii varix [esophageal varices].Burning urination [burning micturition].Constipation [constipation].Ingrow toe nail with pus [ingrown toe nail] ([erythema], [purulent discharge], [edema]).Mild bilateral atelectasis or infiltrate/moderate atelectasis [atelectasis].Positive blood culture candida glabrata [blood culture positive] ([candida test positive]).Vitamin a decreased [vitamin a decreased].Vitamin e decreased [vitamin e decreased].Free t4 decreased [free t4 decreased.Case narrative: initial information received on 11-mar-2020 from united states regarding a legal unsolicited valid serious case from a patient via lawyer.This case involves 19 years old female patient (157.4 cm) who experienced colitis/ c.Diff colitis, pancytopenia, inability to walk on her right foot, decreased mobility, contraction in right foot, abdominal abscess, abdominal discharge, enterocutaneous fistula, infected sepramesh, encapsulated by very dense scar tissue/scarification, severe wound complications, significant mental & physical pain & suffering/emotional distress, physical pain/increased chronic & debilitating pain, headache, sustained permanent injury, substantial physical deformity, mild dizziness after gait, edema noted to iv (intravenous) site, pain to right thumb, still hypotensive, back pain, appetite poor, joint pain/knee pain with walking, pedal edema, nasal discharge, cough, skin warm & dry to touch, feeling anxious, can't sleep, poor physical health, skin warm & dry to touch, threw up bloody vomiting, (l) chest wall pain non radiating to arm, foreign body appeared to be a long plastic stent in stomach/gastric pouch, trace esophageal varices/single grade ii varix, gastric varix, burning urination, constipation, ingrow toe nail with pus, moderate pulmonary edema, findings of congestive failure, mild bilateral atelectasis or infiltrate & positive blood culture candida glabrata, moderate ascites, small pleural effusion, vitamin a decreased, vitamin e decreased & free t4 decreased with the use of medical device carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (sepramesh ip).Past medical history included pancreatic mass in 2005 with (benign mass solid pseudopapillary tumor) & had whipple in (b)(6) 2006 for it, pain (has been 9/10 for 3 days- (b)(6) 2006), mobility decreased (secondary to pain, goal was to try walking when pain reduces), malnutrition, ruq epigastric right upper quadrant pain, local itching over abdomen, amphetamine & marijauna positive social history, large abdominal mass (fluoroscopy interpretation on (b)(6) 2006, diagnostic read of abdomen-(b)(6) 2006 & (b)(6) 2006), ble (bilateral lower extremity) contraction (r>l transfer of tendons), depression, sepsis mrsa, blood per rectum (admitted on (b)(6) 2006, discharged on (b)(6) 2006, bright red blood per rectum, episodic & intermittent colonoscopy on (b)(6) 2012), coagulopathy (with admitted on (b)(6) 2006, discharged on (b)(6) 2006, urinary tract infection with personal nerve palsy t-tube placed on (b)(6) 2006), portal vein thrombosis (portal vein revascularization), multiple surgeries, occupational therapy, midline abdominal wound, acute rehab, gastrostomy & jejunostomy tube, abdominal skin graft, leukocytosis, peripherally inserted central catheterisation (picc) line placement, right ankle contracture, constipation, pain over lat aspect (r) ankle & (r) heel, decreased range of motion (rom), abnormal gait pattern, pancreatic insufficiency, decreased balance, splenomegaly, mild/moderate gastroparesis, right upper extremity (rue) thrombosis, gastritis, gastric bypass, kidney infection, gastric outlet stenosis, difficulty breathing (placed on bilevel positive airway pressure (bipap), need for oxygen), sinus tachycardia, anemia & occasional alcohol & tobacco user.The patient's past medical treatment(s), vaccination(s) & family history were not provided.At the time of the event, the patient had ongoing osteopenia, altered tissue perfusion, portal hypertension, pancreatic cancer/pseudopapillary tumor (pancreas) stage ib, abdominal pain (status post pancreatic mass removal, not relieved by morphine, sharp pain & review of systems included fever, chills , nausea, vomiting & diarrhea, dialudid for it), malignant neoplasm of head of pancreas (with large mass of pancreas with atrophic body & tail endoscopic ultrasound performed, pancreatic cancer for which portal vein resection, reconstruction, exploratory laparotomy performed), allergy to plastic tape, allergy to vancomycin & fentanyl/morphine, reglan, phenergan (rash with morphine & reglan), sepsis (admitted on (b)(6) 2006, then readmitted on (b)(6) 2006 as pat having fever, abdominal pain, biliary & gastric drain, positive culture for mrsa (methicillin resistant staphylococcus aureus) readmitted on (b)(6) 2007), ascending cholangitis (admitted on (b)(6) 2006, again on (b)(6) 2007 )and abnormal periods since whipple (anemia likely as blood loss increased).Patient had right varus foot deformity/bilateral foot contractions in both feet (right foot equinovarus deformity & left foot equinus contracture).On (b)(6) 2007, patient was admitted for bilateral foot contractions in both feet (right >left) (right foot equinovarus deformity & left foot equinus contracture) during extended stay in icu (intensive care unit) for which procedure was performed (foot achilles compactors & ankle capsulotomy) & post operatively, cast to be placed for 4 weeks.Concomitant medications included hydromorphone hydrochloride (dilaudid) for pain & abdominal pain; morphine for pain; paracetamol (tylenol); dextrose; insulin human (novolin r) for blood glucose; promethazine (phenergan) for nausea or vomiting; clindamycin; enoxaparin sodium (lovenox) for deep vein thrombosis (dvt) prophylaxis; famotidine (pepcid); amino acids not otherwise specified (nos), carbohydrates nos, minerals nos, vitamins nos (tpn), famotidine; sodium ferric gluconate complex; sodium chloride; epoetin alfa (epogen); magnesium sulfate; vitamin k; potassium chloride; piperacillin sodium, tazobactam sodium (zosyn); fentanyl; norepinephrine bitartrate (levophed); ondansetron (zofran) for nausea or vomiting; calcium chloride dihydrate, potassium chloride, sodium chloride, sodium lactate (lactated ringers); naloxone hydrochloride (narcan); linezolid (linezolid); gentamycin (gentamycin); sennoside a+b (senokot); ibuprofen (motrin), methadone (methadone); metronidazole (flagyl), fluconazole (diflucan); docusate sodium (colace); lorazepam (ativan); caspofungin; ketorolac tromethamine (toradol); methocarbamol (robaxin); temazepam (restoril) for insomnia; calcium carbonate (maalox) for dyspepsia; nutrients nos (peptamen); heparin; haloperidol (haldol); acetylsalicylic acid (aspirin); salicylic acid (eucerin) & bacitracin.On (b)(6) 2006, patient was implanted with a 20 cm x 30 cm carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (unknown (unk) batch number) for ventral hernia repair.It was reported that physicians used & implanted sepramesh & did not misuse or alter the sepramesh in an unforeseeable manner.Same day, wound culture was positive 2+ enterococcus faecium.On (b)(6) 2006, patient was still hypotensive (onset, latency, unk).On (b)(6) 2006, patient had nausea & abdominal computed tomography (ct) showed new bilateral small pleural effusion, moderate atelectasis, moderate ascites (medically significant), umbilical hernia in mid lowed abdomen (latency: 2 days).On (b)(6) 2006, in pain, had nausea, very distended abdomen, tender & fever, chest radiograph had impression of infiltrates in mid & lower lungs with small pleural effusion.On (b)(6) 2006, chest ra showed moderate pulmonary edema (latency: 4 days, medically significant) & on (b)(6) 2006 had impression of likely diffuse pneumonia versus edema.On (b)(6) 2006, ra chest showed finding of congestive failure (cardiac failure congestive; latency: 6 days, medically significant).On (b)(6) 2006, ra chest showed mild bilateral atelectasis or infiltrates, borderline cardiac size.On (b)(6) 2006, ra chest showed bilateral basilar infiltrates.On (b)(6) 2007, positive blood culture showed candida glabrata, wound culture 4+ pseudomonas aeruginosa (latency: 14 days).On (b)(6) 2007, ra chest showed heart not enlarged, impression of basilar atelectasis especially left lower lobe, on (b)(6) 2007, showed progressive infiltrate/atelectasis at lung bases, (b)(6) 2007: low lung volume, volume overload & (b)(6) 2007: moderate to severe edema.Patient was using wheelchair for her decreased mobility secondary to her inability to walk on her right foot (gait inability) (disability; onset & latency unk).On (b)(6) 2007, patient was noted to have ingrown toe nail with pus (ingrowing nail), toe cuticle erythema, edema, purulent discharge (onset, latency: unk).On an unk date, unk latency patient presented with right upper quadrant abdominal pain radiating to back, pain was 8/10 felt like cramps, medicated with hydromorphone hydrochloride for which patient was admitted on (b)(6) 2007 & ct scan (computerized tomography) showed inflammation of ascending colon for which patient was given intravenous fluids, started on metronidazole & pain was managed.On (b)(6) 2007, again abdomen ct showed inflammation of transverse & descending colon and.Abdominal pain was improved later & had regular diet.Patient was also pan cytopenic during admission (hospitalization, intervention required), but complete blood count was improving.Follow up to be done for biopsies, stool & cbc analysis.Patient also had nausea, vomiting but denied diarrhea & constipation.On an unk date, unk latency, patient had c.Diff colitis (clostridium difficile colitis; medically significant, required intervention, hospitalization).On (b)(6) 2007, patient was alert & had no complaints of abdominal pain.On (b)(6) 2007, edema noted at iv site (localized edema) & pain to right thumb (pain in extremity) (latency 10 months 30 days) cannula intact & encouraged to elevate hand on pillow.On (b)(6) 2007 medicated with paracetamol for headache (onset & latency unk) if any & hydromorphone hydrochloride for abdominal pain with which pain improved to 3/10.Colonoscopy done on (b)(6) 2007 which showed no ulcer & pancytopenia was improving.Assessment & plan included also included: pancreatitis vs hepatitis & anemia improved.On (b)(6) 2007, patient again had a colonoscopy which showed benign colon mucosa & antibiotics used for it.Still having abdominal pain radiated to back (8/10).On an unk date, unk latency, patient had decreased mobility for which gait analysis was performed & patient was issued crutches on (b)(6) 2008, also patient experienced mild dizziness after this.Patient developed contraction in right foot (joint contracture) after prolonged bed rest from her abdominal surgery (onset & latency unk) for which patient undergone right foot triple arthrodesis procedure with possible bone allograft versus bone autograft from right versus left, got hospitalized for the same on (b)(6) 2008, pain was 8/10 but appeared calm, alert, aware, foot intact but crying for pain, on morphine.On (b)(6) 2008, patient denied pain now however wanted to have intravenous pain medicine & then pain was controlled after using iv antibiotics.Patient passed physical therapy on (b)(6) 2008, standing with crutches & got discharged the same day.Follow up in orthopedic clinic in 2 weeks.Assessment included to start on intravenous fluids.On (b)(6) 2008, patient was ready to walk, mobility improved, alert, vital signs stable, medicated with hydromorphone hydrochloride, tolerated well.On an unk date, unk latency, the patient experienced abdominal abscess (medically significant, required intervention) having serosanguinous fluid, blood coloured drainage, yellowish green secretions & on (b)(6) 2017 underwent surgery to address it.During the procedure, the surgeons observed that the infected carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (device related infection) was only partially incorporated with the abdominal wall & was encapsulated by very dense scar tissue (implant site scar) & pus (purulent discharge).Due to the dense scarification, the surgeons were forced to leave a portion of the failed carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate in patient's abdomen.Following this procedure, on an unk date, the patient developed enterocutaneous fistula (medically significant) & severe wound complications & had be placed on total parenteral nutrition via an implanted port.On an unk date, the patient experienced significant mental & physical pain & suffering (emotional distress), had sustained permanent injury, permanent & substantial physical deformity, had undergone corrective surgery & reportedly would be undergoing corrective surgery or surgeries.It was reported that the mesh was defective in its design (product design issue), defective in its manufacture & construction (manufacturing production issue).Although its design was used to prevent or minimize hernia recurrence & chronic pain, the design did not do so (device ineffective).Instead, the design increased the intense inflammatory & chronic foreign body response, which resulted in mesh contracture, mesh deformation, mesh migration, granulomatous and/or fibrotic tissue, increased foreign body sensation, increased chronic & debilitating pain, & infection.The defective & unreasonably dangerous condition of the device was the proximate cause of the damages & injuries complained by the patient.On (b)(6) 2010, noted to have knee pain intermittent with walking (onset, latency: unk).On (b)(6) 2010, impression of constipation, side flank pain, nausea, vomiting, edema, dry & warm skin (onset, latency: unk).On (b)(6) 2011, patient had impression of constipation, flank pain, nausea, vomiting, edema, dry & warm skin & there was no evidence of obstruction.On (b)(6) 2012, (latency: 5 years 1 month 12 days) the patient's lab test showed vitamin a: 10 mcg/dl (low)(reference range: 38-98 mcg/dl) & vitamin e 1.8 mg/l (low) (reference range: 5.7-19.9 mg/l) (vitamin a decreased, & vitamin e decreased).On (b)(6) 2012, patient admitted to hospital for foreign body appeared to be a long plastic stent in stomach/gastric pouch (foreign body in gastrointestinal tract; required intervention), noted to have burning urination (dysuria), vomiting, nausea, abdominal pain sharp, constant, getting worse, radiating to back (onset, latency: unk).On (b)(6) 2012, due to abdominal pain esophagogastroduodenoscopy with foreign body removal with balloon dilation was done which showed gastritis, gastric outlet stenosis which was diluted, trace esophageal varices, gastric varix (medically significant) (onset, latency: unk).On (b)(6) 2012, had surgery due to vomiting showed esophageal single grade ii varix & esophagogastroduodenoscopy was done & patient was told to avoid opioids or other medications that can contribute to gastroparesis.On (b)(6) 2012, patient was discharged.On (b)(6) 2012, had back pain, fever, vomiting, nausea, abdominal pain, skin warm (onset, latency: unk).On (b)(6) 2012, noted to have weight loss, poor appetite (decreased appetite), nausea constipation, vomiting, & on (b)(6) 2012, pedal edema (oedema peripheral), distended abdomen, (onset, latency: unk) admitted for abdominal pain, given iv & oral antibiotics for possible colitis & patient discharged against medical advice same day.On unk date, unk latency, patient had cough & nasal discharge (rhinorrhoea).On (b)(6) 2012, mentioned feeling anxious (anxiety) & could not sleep (insomnia), weight loss, nausea/vomiting, abdominal & back pain, poor physical health (general physical health deterioration), skin warm & dry to touch, threw up blood vomiting (haematemesis; medically significant) (onset, latency: unk) & discharged cancelled.Patient also complained of (l) chest pain non radiating to arms (musculoskeletal chest pain; onset, latency: unk), no shortness of breath.On (b)(6) 2012, lab test showed vitamin a: 7 mcg/dl & vitamin e of 1.5 mg/l.On (b)(6) 2020 after a latency of 13 years 1 month 24 days lab test revealed free thyroxine (t4) level 0.8 ng/dl (thyroxine free decreased) (ref range: 0.9-2.2 ng/dl) & on(b)(6) 2020 it was 1.8 ng/dl (normal).Relevant lab test results included: colonoscopy - on (b)(6) 2007: [showed no ulcer]; computerized tomogram - on (b)(6) 2007: [inflammation of ascending colon, fatty infiltration of liver, pancreas atrophic, kidneys are unremarkable, no abnormality in pelvis]; on (b)(6) 2007: [inflammation of transverse & descending colon]; lymphocyte count (1.2 - 3.2 10*9/l) - on (b)(6) 2007: 0.3 10*9/l [low]; lymphocyte percentage (17 - 48 %) - on (b)(6) 2007: 6.5 % [low]; monocyte count (0.3 - 0.8 10*9/l) - on (b)(6) 2007: 0 10*9/l [low]; monocyte percentage (4 - 10 %) - on (b)(6) 2007: 1.8 % [low]; red blood cell count (3.3 - 5.6 10*12/l) - on (b)(6) 2007: 3.2 10*12/l [low]; on (b)(6) 2007: 3.04 10*12/l [low]; on (b)(6) 2007: 3.06 10*12/l [low]; on (b)(6) 2007: 3.09 10*12/l; rle exam (right lower extremity) - on (b)(6) 2008: [slc elevated 3 pillows, n/v/m grossly intact r toes]; white blood cell count (4.3 - 11.3 10*9/l) - on (b)(6) 2007: 3.5 10*9/l [low]; on (b)(6) 2007: 2.5 10*9/l [low]; on (b)(6) 2007: 2.3 10*9/l [low]; on (b)(6) 2007: 3.1 10*9/l [low].Action taken- not applicable for all events.Corrective treatment: surgery, total parenteral nutrition, implanted port for abdominal abscess; colonoscopy, ct (computerized tomography) pelvis & abdomen, ivf(intravenous fluids), iv & oral antibiotics for colitis/ c.Diff colitis & pan cytopenia; right foot triple arthrodesis for contraction in right foot; tylenol for headache; diladaud for abdominal pain, wheelchair for inability to walk on her right foot; crutches issued to patient, gait training for mobility decreased; cleanse, sterile non adherent dressing, cefalosporin, cefalin (keflex), magnesium sulfate (epson salt) for ingrow toe nail with pus, surgical removal for foreign body appeared to be a long plastic stent in stomach/gastric pouch, hydrocodone bitartrate, paracetamol (norco) for (l) chest wall pain non radiating to arm, nsaids (non-steroidal anti-inflammatory drugs) & ibuprofen for joint pain/knee pain with walking, not reported for rest of the events.Outcome: recovered for skin warm & dry to touch, free t4 decreased; recovering for ruq abdominal pain radiating to back/ pain is 8/10 in ruq feels like cramps/chronic abdominal pain/l sided radiates to r, nausea, very distended abdomen, tender abdomen, unk for rest of the events.A product technical complaint was initiated, & results were pending for the same.Additional information received on 23-jul-2020 from non-healthcare professional.Patient demographics were added.Additional information received on 19-aug-2020 from lawyer.Hospital discharge summary processed.Medical history, concurrent conditions, concomitant medications added.Labs added.Events of contracture in right foot, decreased mobility, mild dizziness after gait, colitis, pancytopenia, edema noted to iv site, pain to right thumb & inability to walk on her right foot added.Additional information received on 24-aug-2020 from lawyer.Events of hypotensive, back pain, appetite poor, joint pain/knee pain with walking, pedal edema, nasal discharge, cough, skin warm & dry to touch, feeling anxious, can't sleep, poor physical health, skin warm & dry to touch, threw up bloody vomiting, (l) chest wall pain non radiating to arm, sob, foreign body appeared to be a long plastic stent in stomach/gastric pouch, trace esophageal varices/single grade ii varix, gastroc varix, burning urination, constipation, ingrow toe nail with pus, moderate pulmonary edema, findings of congestive failure, mild bilateral atelectasis or infiltrate & positive blood culture candida glabrata added.Medical history, concomitant medications, labs updated.On (b)(6) 2020, with clock start date of (b)(6) 2020, significant amendment performed for case submission of last follow up version.Additional information received on 25-sep-2020 from non-healthcare professional.Events of vitamin a decreased, vitamin e decreased & free t4 decreased were added.Clinical course updated & text amended accordingly.

Event Description

Findings of congestive failure [congestive cardiac failure] moderate pulmonary edema [pulmonary edema] gastric varix [gastric varices] foreign body appeared to be a long plastic stent in stomach/gastric pouch [foreign body in stomach] threw up bloody vomiting [vomiting blood] pancytopenia [pancytopenia] contraction in right foot [contracture of lower leg joint] decreased mobility [mobility decreased] inability to walk on her right foot [unable to walk] moderate ascites [ascites] colitis/ c.Diff colitis [clostridium difficile colitis] ([nausea], [vomiting], [abdominal tenderness], [tachycardia], [chronic abdominal pain], [abdominal distension], [fever], [diarrhea], [radiating pain]) abdominal abscess [abdominal abscess] ([device ineffective], [purulent discharge], [manufacturing production issue], [product design issue], [serous discharge]) enterocutaneous fistula [enterocutaneous fistula] infected sepramesh [device related infection] encapsulated by very dense scar tissue/scarification [implant site scar] severe wound complications [wound complication] ([culture wound positive], [enterococcus test positive], [pseudomonas aeruginosa test positive]) significant mental and physical pain and suffering/emotional distress [emotional suffering] physical pain/increased chronic and debilitating pain [pain] headache [headache] sustained permanent injury [permanent injury] substantial physical deformity [acquired deformity nos] mild dizziness after gait [dizziness] small pleural effusion [pleural effusion] edema noted to iv site [injection site oedema] pain to right thumb [pain in thumb] still hypotensive [hypotensive] back pain [back pain] appetite poor [appetite decreased nos] ([weight loss]) joint pain/knee pain with walking [joint pain] ([pain upon movement]) pedal edema [pedal edema] nasal discharge [nasal discharge] cough [cough] skin warm and dry to touch [skin warm] feeling anxious [feeling anxious] can't sleep [difficulty sleeping] poor physical health [general physical health deterioration] skin warm and dry to touch [skin dry] (l) chest wall pain non radiating to arm [chest wall pain] trace esophageal varices/single grade ii varix [esophageal varices] burning urination [burning micturition] constipation [constipation] ingrow toe nail with pus [ingrown toe nail] ([erythema], [purulent discharge], [edema]) mild bilateral atelectasis or infiltrate/moderate atelectasis [atelectasis] positive blood culture candida glabrata [blood culture positive] ([candida test positive]) vitamin a decreased [vitamin a decreased] vitamin e decreased [vitamin e decreased] free t4 decreased [free t4 decreased] case narrative: initial information received on 11-mar-2020 from united states regarding a legal unsolicited valid serious case from a patient via lawyer.This case involves 19 years old female patient (157.4 cm) who experienced colitis/ c.Diff colitis, pancytopenia, inability to walk on her right foot, decreased mobility, contraction in right foot, abdominal abscess, abdominal discharge, enterocutaneous fistula, infected sepramesh, encapsulated by very dense scar tissue/scarification, severe wound complications, significant mental & physical pain & suffering/emotional distress, physical pain/increased chronic & debilitating pain, headache, sustained permanent injury, substantial physical deformity, mild dizziness after gait, edema noted to iv (intravenous) site, pain to right thumb, still hypotensive, back pain, appetite poor, joint pain/knee pain with walking, pedal edema, nasal discharge, cough, skin warm & dry to touch, feeling anxious, can't sleep, poor physical health, threw up bloody vomiting, (l) chest wall pain non radiating to arm, foreign body appeared to be a long plastic stent in stomach/gastric pouch, trace esophageal varices/single grade ii varix, gastric varix, burning urination, constipation, ingrow toe nail with pus, moderate pulmonary edema, findings of congestive failure, mild bilateral atelectasis or infiltrate & positive blood culture candida glabrata, moderate ascites, small pleural effusion, vitamin a decreased, vitamin e decreased & free t4 decreased with the use of medical device carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (sepramesh ip).Past medical history included pancreatic mass in 2005 with (benign mass solid pseudopapillary tumor) & had whipple in (b)(6) 2006 for it, pain (has been 9/10 for 3 days- (b)(6) 2006), mobility decreased (secondary to pain, goal was to try walking when pain reduces), biliary stricture with balloon dilation, migraine, malnutrition, ruq epigastric right upper quadrant pain, local itching over abdomen, amphetamine & marijuana positive social history, large abdominal mass (fluoroscopy interpretation on (b)(6) 2006, diagnostic read of abdomen-(b)(6) 2006), ble (bilateral lower extremity) contraction (r>l transfer of tendons), depression, sepsis mrsa, blood per rectum (admitted on (b)(6) 2006, discharged on (b)(6) 2006, bright red blood per rectum, episodic & intermittent colonoscopy on (b)(6) 2012), coagulopathy (with admitted on (b)(6) 2006, discharged on (b)(6) 2006, urinary tract infection with personal nerve palsy t-tube placed on (b)(6) 2006), portal vein thrombosis (portal vein revascularization), multiple surgeries, occupational therapy, midline abdominal wound, acute rehab, gastrostomy & jejunostomy tube, abdominal skin graft, leukocytosis, peripherally inserted central catheterisation (picc) line placement, right ankle contracture, constipation, pain over lat aspect (r) ankle & (r) heel, decreased range of motion (rom), abnormal gait pattern, pancreatic insufficiency, decreased balance, splenomegaly, mild/moderate gastroparesis, right upper extremity (rue) thrombosis, gastritis, gastric bypass, kidney infection, gastric outlet stenosis, difficulty breathing (placed on bilevel positive airway pressure (bipap), need for oxygen), sinus tachycardia, anemia & occasional alcohol & tobacco user.The patient's past medical treatment(s), vaccination(s) & family history were not provided.At the time of the event, the patient had ongoing osteopenia, altered tissue perfusion, portal hypertension, pancreatic cancer/pseudopapillary tumor (pancreas) stage ib, abdominal pain (status post pancreatic mass removal, not relieved by morphine, sharp pain & review of systems included fever, chills , nausea, vomiting & diarrhea, dialudid for it), malignant neoplasm of head of pancreas (with large mass of pancreas with atrophic body & tail endoscopic ultrasound performed, pancreatic cancer for which portal vein resection, reconstruction, exploratory laparotomy performed), allergy to plastic tape, allergy to vancomycin & fentanyl/morphine, reglan, phenergan (rash with morphine & reglan), sepsis (admitted on (b)(6) 2006, then readmitted on (b)(6) 2006 as pat having fever, abdominal pain, biliary & gastric drain, positive culture for mrsa (methicillin resistant staphylococcus aureus) readmitted on (b)(6) 2007), ascending cholangitis (admitted on (b)(6) 2006, again on (b)(6) 2007 )and abnormal periods since whipple (anemia likely as blood loss increased).Patient had right varus foot deformity/bilateral foot contractions in both feet (right foot equinovarus deformity & left foot equinus contracture).On (b)(6) 2007, patient was admitted for bilateral foot contractions in both feet (right >left) (right foot equinovarus deformity & left foot equinus contracture) during extended stay in icu (intensive care unit) for which procedure was performed (foot achilles compactors & ankle capsulotomy) & post operatively, cast to be placed for 4 weeks.Concomitant medications included hydromorphone hydrochloride (dilaudid) for pain & abdominal pain; morphine for pain; paracetamol (tylenol); dextrose; insulin human (novolin r) for blood glucose; promethazine (phenergan) for nausea or vomiting; clindamycin; enoxaparin sodium (lovenox) for deep vein thrombosis (dvt) prophylaxis; famotidine (pepcid); amino acids not otherwise specified (nos), carbohydrates nos, minerals nos, vitamins nos (tpn), famotidine; sodium ferric gluconate complex; sodium chloride; epoetin alfa (epogen); magnesium sulfate; vitamin k; potassium chloride; piperacillin sodium, tazobactam sodium (zosyn); fentanyl; norepinephrine bitartrate (levophed); ondansetron (zofran) for nausea or vomiting; calcium chloride dihydrate, potassium chloride, sodium chloride, sodium lactate (lactated ringers); naloxone hydrochloride (narcan); linezolid (linezolid); gentamycin (gentamycin); sennoside a+b (senokot); ibuprofen (motrin), methadone (methadone); metronidazole (flagyl), fluconazole (diflucan); docusate sodium (colace); lorazepam (ativan); caspofungin; ketorolac tromethamine (toradol); methocarbamol (robaxin); temazepam (restoril) for insomnia; calcium carbonate (maalox) for dyspepsia; nutrients nos (peptamen); heparin; haloperidol (haldol); acetylsalicylic acid (aspirin); salicylic acid (eucerin), diphenhydramine hydrochloride (benadryl), esomeprazole sodium (nexium) & bacitracin.On (b)(6) 2006, patient was implanted with a 20 cm x 30 cm carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (unknown (unk) batch number) for ventral hernia repair.It was reported that physicians used & implanted sepramesh & did not misuse or alter the sepramesh in an unforeseeable manner.Same day, wound culture was positive 2+ enterococcus faecium.On (b)(6) 2006, patient was still hypotensive (onset, latency, unk).On (b)(6)2006, patient had nausea & abdominal computed tomography (ct) showed new bilateral small pleural effusion, moderate atelectasis, moderate ascites (medically significant), umbilical hernia in mid lowed abdomen (latency: 2 days).On (b)(6) 2006, in pain, had nausea, very distended abdomen, tender & fever, chest radiograph had impression of infiltrates in mid & lower lungs with small pleural effusion.On (b)(6)2006, chest ra showed moderate pulmonary edema (latency: 4 days, medically significant) & on (b)(6) 2006 had impression of likely diffuse pneumonia versus edema.On (b)(6) 2006, ra chest showed finding of congestive failure (cardiac failure congestive; latency: 6 days, medically significant).On (b)(6) 2006, ra chest showed mild bilateral atelectasis or infiltrates, borderline cardiac size.On (b)(6)2006, ra chest showed bilateral basilar infiltrates.On (b)(6)2007, positive blood culture showed candida glabrata, wound culture 4+ pseudomonas aeruginosa (latency: 14 days).On (b)(6)2007, ra chest showed heart not enlarged, impression of basilar atelectasis especially left lower lobe, on (b)(6)2007, showed progressive infiltrate/atelectasis at lung bases, (b)(6)2007: low lung volume, volume overload & (b)(6)2007: moderate to severe edema.Patient was using wheelchair for her decreased mobility secondary to her inability to walk on her right foot (gait inability) (disability; onset & latency unk).On (b)(6)2007, patient was noted to have ingrown toe nail with pus (ingrowing nail), toe cuticle erythema, edema, purulent discharge (onset, latency: unk).On an unk date, unk latency patient presented with right upper quadrant abdominal pain radiating to back, pain was 8/10 felt like cramps, medicated with hydromorphone hydrochloride for which patient was admitted on (b)(6)2007 & ct scan (computerized tomography) showed inflammation of ascending colon for which patient was given intravenous fluids, started on metronidazole & pain was managed.On (b)(6)2007, again abdomen ct showed inflammation of transverse & descending colon and.Abdominal pain was improved later & had regular diet.Patient was also pan cytopenic during admission (hospitalization, intervention required), but complete blood count was improving.Follow up to be done for biopsies, stool & cbc analysis.Patient also had nausea, vomiting but denied diarrhea & constipation.On an unk date, unk latency, patient had c.Diff colitis (clostridium difficile colitis; medically significant, required intervention, hospitalization).On (b)(6)2007, patient was alert & had no complaints of abdominal pain.On (b)(6)2007, edema noted at iv site (localized edema) & pain to right thumb (pain in extremity) (latency 10 months 30 days) cannula intact & encouraged to elevate hand on pillow.On (b)(6)2007 medicated with paracetamol for headache (onset & latency unk) if any & hydromorphone hydrochloride for abdominal pain with which pain improved to 3/10.Colonoscopy done on (b)(6)2007 which showed no ulcer & pancytopenia was improving.Assessment & plan included also included: pancreatitis vs hepatitis & anemia improved.On (b)(6)2007, patient again had a colonoscopy which showed benign colon mucosa & antibiotics used for it.Still having abdominal pain radiated to back (8/10).On an unk date, unk latency, patient had decreased mobility for which gait analysis was performed & patient was issued crutches on (b)(6) 2008, also patient experienced mild dizziness after this.Patient developed contraction in right foot (joint contracture) after prolonged bed rest from her abdominal surgery (onset & latency unk) for which patient undergone right foot triple arthrodesis procedure with possible bone allograft versus bone autograft from right versus left, got hospitalized for the same on (b)(6)2008, pain was 8/10 but appeared calm, alert, aware, foot intact but crying for pain, on morphine.On (b)(6)2008, patient denied pain now however wanted to have intravenous pain medicine & then pain was controlled after using iv antibiotics.Patient passed physical therapy on (b)(6)2008, standing with crutches & got discharged the same day.Follow up in orthopedic clinic in 2 weeks.Assessment included to start on intravenous fluids.On (b)(6)2008, patient was ready to walk, mobility improved, alert, vital signs stable, medicated with hydromorphone hydrochloride, tolerated well.On an unk date, unk latency, the patient experienced abdominal abscess (medically significant, required intervention) having serosanguinous fluid, blood coloured drainage, yellowish green secretions.During the procedure, the surgeons observed that the infected carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate (device related infection) was only partially incorporated with the abdominal wall & was encapsulated by very dense scar tissue (implant site scar) & pus (purulent discharge).Due to the dense scarification, the surgeons were forced to leave a portion of the failed carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate in patient's abdomen.Following this procedure, on an unk date, the patient developed enterocutaneous fistula (medically significant) & severe wound complications & had be placed on total parenteral nutrition via an implanted port.On an unk date, the patient experienced significant mental & physical pain & suffering (emotional distress), had sustained permanent injury, permanent & substantial physical deformity, had undergone corrective surgery & reportedly would be undergoing corrective surgery or surgeries.It was reported that the mesh was defective in its design (product design issue), defective in its manufacture & construction (manufacturing production issue).Although its design was used to prevent or minimize hernia recurrence & chronic pain, the design did not do so (device ineffective).Instead, the design increased the intense inflammatory & chronic foreign body response, which resulted in mesh contracture, mesh deformation, mesh migration, granulomatous and/or fibrotic tissue, increased foreign body sensation, increased chronic & debilitating pain, & infection.The defective & unreasonably dangerous condition of the device was the proximate cause of the damages & injuries complained by the patient.On (b)(6)2010, noted to have knee pain intermittent with walking (onset, latency: unk).On (b)(6)2010, impression of constipation, side flank pain, nausea, vomiting, edema, dry & warm skin (onset, latency: unk).On (b)(6)2011, patient had the symptoms again with no evidence of obstruction.On (b)(6)2012, (latency: 5 years 1 month 12 days) the patient's lab test showed vitamin a: 10 mcg/dl (low)(reference range: 38-98 mcg/dl) & vitamin e 1.8 mg/l (low) (reference range: 5.7-19.9 mg/l) (vitamin a decreased, & vitamin e decreased).On (b)(6)2012, patient admitted to hospital for foreign body appeared to be a long plastic stent in stomach/gastric pouch (foreign body in gastrointestinal tract; required intervention), noted to have burning urination (dysuria), vomiting, nausea, abdominal pain sharp, constant, getting worse, radiating to back (onset, latency: unk).On (b)(6)2012, due to abdominal pain esophagogastroduodenoscopy with foreign body removal with balloon dilation was done which showed gastritis, gastric outlet stenosis which was diluted, trace esophageal varices, gastric varix (medically significant) (onset, latency: unk).On (b)(6)2012, had surgery due to vomiting showed esophageal single grade ii varix & esophagogastroduodenoscopy was done & patient was told to avoid opioids or other medications that can contribute to gastroparesis.On (b)(6)2012, patient was discharged.On (b)(6)2012, had back pain, fever, vomiting, nausea, abdominal pain, skin warm (onset, latency: unk).On (b)(6)2012, noted to have weight loss, poor appetite (decreased appetite), nausea constipation, vomiting, & on (b)(6)2012, pedal edema (oedema peripheral), distended abdomen, (onset, latency: unk) admitted for abdominal pain, given iv & oral antibiotics for possible colitis & patient discharged against medical advice same day.On unk date, unk latency, patient had cough & nasal discharge (rhinorrhoea).On (b)(6)2012, mentioned feeling anxious (anxiety) & could not sleep (insomnia), weight loss, nausea/vomiting, abdominal & back pain, poor physical health (general physical health deterioration), skin warm & dry to touch, threw up blood vomiting (haematemesis; medically significant) (onset, latency: unk) & discharged cancelled.Patient also complained of (l) chest pain non radiating to arms (musculoskeletal chest pain; onset, latency: unk), no shortness of breath.On (b)(6)2012, lab test showed vitamin a: 7 mcg/dl & vitamin e of 1.5 mg/l.On (b)(6)2017 underwent surgery to address abdominal abscess.On (b)(6)2020 after a latency of 13 years 1 month 24 days lab test revealed free thyroxine (t4) level 0.8 ng/dl (thyroxine free decreased) (ref range: 0.9-2.2 ng/dl) & on (b)(6)2020 it was 1.8 ng/dl (normal).Relevant lab test results included: colonoscopy - on (b)(6)2007: [showed no ulcer]; computerized tomogram - on (b)(6)2007: [inflammation of ascending colon, fatty infiltration of liver, pancreas atrophic, kidneys are unremarkable, no abnormality in pelvis]; on (b)(6)2007: [inflammation of transverse & descending colon]; lymphocyte count (1.2 - 3.2 10*9/l) - on (b)(6)2007: 0.3 10*9/l [low]; lymphocyte percentage (17 - 48 %) - on (b)(6)2007: 6.5 % [low]; monocyte count (0.3 - 0.8 10*9/l) - on (b)(6)2007: 0 10*9/l [low]; monocyte percentage (4 - 10 %) - on (b)(6)2007: 1.8 % [low]; red blood cell count (3.3 - 5.6 10*12/l) - on (b)(6)2007: 3.2 10*12/l [low]; on (b)(6)2007: 3.04 10*12/l [low]; on (b)(6)2007: 3.06 10*12/l [low]; on (b)(6)2007: 3.09 10*12/l; rle exam (right lower extremity) - on (b)(6)2008: [slc elevated 3 pillows, n/v/m grossly intact r toes]; white blood cell count (4.3 - 11.3 10*9/l) - on (b)(6)2007: 3.5 10*9/l [low]; on (b)(6)2007: 2.5 10*9/l [low]; on (b)(6)2007: 2.3 10*9/l [low]; on (b)(6)2007: 3.1 10*9/l [low].Action taken- not applicable for all events: corrective treatment: surgery, total parenteral nutrition, implanted port for abdominal abscess; colonoscopy, ct (computerized tomography) pelvis & abdomen, ivf(intravenous fluids), iv & oral antibiotics for colitis/ c.Diff colitis & pan cytopenia; right foot triple arthrodesis for contraction in right foot; tylenol for headache; diladaud for abdominal pain, wheelchair for inability to walk on her right foot; crutches issued to patient, gait training for mobility decreased; cleanse, sterile non adherent dressing, cefalosporin, cefalin (keflex), magnesium sulfate (epson salt) for ingrow toe nail with pus, surgical removal for foreign body appeared to be a long plastic stent in stomach/gastric pouch, hydrocodone bitartrate, paracetamol (norco) for (l) chest wall pain non radiating to arm, nsaids (non-steroidal anti-inflammatory drugs) & ibuprofen for joint pain/knee pain with walking, alprazolam (xanax) for feeling anxious, can't sleep; not reported for rest of the events.Outcome: recovered for skin warm & dry to touch, free t4 decreased; recovering for ruq abdominal pain radiating to back/ pain is 8/10 in ruq feels like cramps/chronic abdominal pain/l sided radiates to r, nausea, very distended abdomen, tender abdomen, unk for rest of the events.A product technical complaint was initiated, & results were pending for the same.Additional information received on 23-jul-2020 from non-healthcare professional.Patient demographics were added.Additional information received on 19-aug-2020 from lawyer.Hospital discharge summary processed.Medical history, concurrent conditions, concomitant medications added.Labs added.Events of contracture in right foot, decreased mobility, mild dizziness after gait, colitis, pancytopenia, edema noted to iv site, pain to right thumb & inability to walk on her right foot added.Additional information received on 24-aug-2020 from lawyer.Events of hypotensive, back pain, appetite poor, joint pain/knee pain with walking, pedal edema, nasal discharge, cough, skin warm & dry to touch, feeling anxious, can't sleep, poor physical health, skin warm & dry to touch, threw up bloody vomiting, (l) chest wall pain non radiating to arm, sob, foreign body appeared to be a long plastic stent in stomach/gastric pouch, trace esophageal varices/single grade ii varix, gastroc varix, burning urination, constipation, ingrow toe nail with pus, moderate pulmonary edema, findings of congestive failure, mild bilateral atelectasis or infiltrate & positive blood culture candida glabrata added.Medical history, concomitant medications, labs updated.On 25-sep-2020, with clock start date of 24-aug-2020, significant amendment performed for case submission of last follow up version.Additional information received on 25-sep-2020 from non-healthcare professional.Events of vitamin a decreased, vitamin e decreased & free t4 decreased were added.Clinical course updated & text amended accordingly.Additional information received on 12-oct-2020 from healthcare professional.Medical history and concomitant medications updated.Treatment added for feeling anxious.Clinical course updated & text amended accordingly.

• Brand Name: SEPRAMESH IP
• Type of Device: MCN
• Manufacturer (Section D): GENZYME BIOSURGERY (SEPRAMESH); 76 new york avenue; framingham 01701
• MDR Report Key: 9871396
• MDR Text Key: 196553310
• Report Number: 1221601-2020-00001
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/27/2020; 08/27/2020; 09/25/2020; 10/06/2020; 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability