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| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 05/26/2005 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2003 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2005, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: removal of unincorporated gore mesh, chronic mesh infection, draining skin fistula from the abdomen, recurrent hernia defect noted, wound revision.Additional event specific information was not provided.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: on (b)(6) 2001: (b)(6) medical health system.(b)(6) , md.Operative report.Preoperative diagnosis: biliary dyskinesia.Postoperative diagnosis: biliary dyskinesia.Operation: laparoscopic cholecystectomy.On (b)(6) 2002: (b)(6) medical health system.(b)(6) , md.History and physical.Evaluation for uterine bleeding and uterine fibroids.Weight 286 pounds.Exam: abdomen soft with no distinct palpable masses noted.Impression/plan: abnormal uterine bleeding; uterine fibroids; menorrhagia; pelvic pain; previous cesarean section x2; morbid obesity.Plan to proceed with a total abdominal hysterectomy with evaluation of ovaries.On (b)(6) 2002: (b)(6) medical health system.(b)(6) , md.Operative report.Preoperative diagnosis: abnormal uterine bleeding; menorrhagia; uterine hypertrophy; morbid obesity; c-section x2.Postoperative diagnosis: same.Procedure: total abdominal hysterectomy and lysis of adhesions with altered surgical field secondary to the patient¿s morbid obesity and adhesions.On (b)(6) 2003: (b)(6) diagnostic center.(b)(6) , md.Radiology-ct abdomen/pelvis without contrast.Indication: incisional knot pelvic area since hysterectomy in october.Findings: the large area of fluid collection is noted in the suprapubic anterior abdominal wall which measures up to 6 x 4 cm.The patient body habitus is limiting the evaluation and looks like there is also possibility of post operative hernia with intestinal loops in the fat outpouching towards the pubis without evidence of obstruction or incarceration.Impression: possible post operative hernia and fluid collection in the suprapubic incisional region best seen at image #16 through 20.No incarceration or obstruction are seen.Findings likely representing post operative seroma, hematoma, versus developing small abscess.No air fluid level to suggest abscess at this point.On (b)(6) 2003: (b)(6) medical health system.(b)(6) , md.Operative report.Preoperative diagnosis: incisional hernia.Postoperative diagnosis: same.Operation performed: repair of incisional hernia with marlex mesh.First assistant: (b)(6) , md.Second assistant: (b)(6) , cfa.Anesthesia: general.Estimated blood loss: 400 cc.Consent: a preoperative informed consent discussion had previously been held with the patient and is documented in the history and physical.Description of procedure: ¿after preoperative antibiotics and heparin and scds, the patient was taken to the operating room where she was placed on the operating table supine.After induction of general endotracheal anesthesia, the abdomen was prepped and draped sterile.A low vertical midline incision was made sharply and carried down into the subcutaneous fat with electrocautery.We dissected down to the hernia sac and dissected it back worked it out of a skin flap.The hernia sac was dissected out away from the skin but was very close to the skin.We entered the hernia sac and freed up many omental adhesions with very little small bowel that was actually involved.When we brought down the omentum, the sac was dissected back to the fascia on all sides.With that done, we placed serial #1 prolenes approximately a centimeter apart all the way around the large hernia defect.With that done, we grasped the fascia out of the rectus that had been split in the middle and were able to reapproximate it in the midline with #1 prolene.We then trimmed and reapproximated the hernia sac with 0 vicryl and then placed an onlay marlex mesh tied down with the sutures that had previously been tagged down.The mesh had been soaked in antibiotic-impregnated saline.We irrigated and suctioned with antibiotic-impregnated saline.I closed a deep layer with 3-0 vicryl and placed a subcutaneous drain brought out through a separate stab incision.We then again copiously irrigated and suctioned and closed the midline with staples and hooked the drain to bulb suction.Attention was then turned back to the pouch of skin hanging off the bottom of the patient¿s pannus.Having dissected so close to it, it was beginning to show obvious ischemia and was already obviously an open sac where fluid would collect.Therefore i amputated the excess skin and closed it to separate it from the hernia repair with 2-0 vicryls and then closed the 3-0 vicryl deep and staples on the skin.All incisions were washed and dressed sterile.The patient tolerated the procedure well.Sponge, needle, and instrument count were correct.Anesthesia was reversed and she was extubated, taken to recovery room in stable condition.¿ on (b)(6) 2003: (b)(6) medical health system.(b)(6) , md.History and physical.Ms.(b)(6) is a 33-year-old woman who in (b)(6) 2002, had an abdominal hysterectomy for abnormal uterine bleeding and uterine fibroids.She developed a large hernia postoperatively and presented to me.On the (b)(6) this year, she went to the operating room where she underwent a repair of her hernia.It was a primary repair with a marlex mesh onlay.She had been sent home and was doing well.When she came into the office on the (b)(6) , she had been draining pus out of her abdomen for several days.She was having low grade fevers and general malaise and i made the decision to admit her to the hospital then.History of cesarean section, gallbladder surgery, morbid obesity.Neither smokes or drinks.Exam: abdomen is soft.Her upper incision appears well healed.Her lower incision appears well healed, however, she has fistula that has abscessed through the skin in the right lower quadrant.Impression: infected mesh hernia repair.Plan: admit to hospital for surgery on the same day with the possibility of mesh removal.On (b)(6) 2003: (b)(6) medical health system.(b)(6) er, md.Operative report.Preoperative diagnosis: infected mesh repair of ventral hernia.Postoperative diagnosis: same.Procedure performed: debridement, irrigation and packing of abscess cavity.Anesthesia: general by dr.(b)(6).Estimated blood loss: less than 50 cc.Specimen: none.Drains: none.A performed informed consent discussion had been held with the patient as documented in the history and physical.Description of procedure: ¿the patient was taken to the operating room where she was placed on the operating table supine after insertion of a central venous line.She was then placed under general endotracheal anesthesia and her abdomen was prepped and draped sterile.I opened the previous midline incision down into the abscess cavity which was immediately overlying the mesh.We drained out all the pus and irrigated it.She had a small fistula formation to the skin which was where she had been draining her pus.I removed the suture holding the mesh that was closest to this and then sutured the skin shut with 2-0 prolene.We copiously irrigated the abdominal incision multiple times with antibiotic impregnated saline.On inspection i was able to find that the mesh was granulating in from the outside.It was otherwise fairly healthy and therefore i elected to pack it with betadine-soaked gauze and bring her back in two days for a dressing change.She was packed and dressed.Anesthesia, reversed and she was awakened, taken to the recovery room in stable condition.¿ on (b)(6) 2003: (b)(6) medical health system.(b)(6) , md.Operative report.Procedure: dressing change under anesthesia.Consent: preoperative informed consent discussion was held with the patient where we discussed the nature and risks of her having another anesthesia.However, she has a large incision and there is a concern that during the dressing change i may make a decision to remove the mesh and, therefore, she is having it under general anesthesia.Procedure: ¿patient was brought to the operating room.Placed on the operating table in the supine.After induction of general endotracheal anesthesia, i unpacked, examined, irrigated out, and repacked her abdomen without difficulty.She tolerated the procedure well.Anesthesia was reversed and she was taken to recovery.No apparent complications.¿ on (b)(6) 2003: (b)(6) medical health system.(b)(6) , md.Radiology-ct abdomen/pelvis.Indication: abdominal pain.Findings: within the pelvis there is an oval density measuring about 4 cm in diameter in the left iliac fossa.This appears to lie above the bladder and to the left of midline.It could represent an ovarian mass or an ovarian cyst.The patient refused contrast material which significantly limits the ability to characterize this mass.I would favor it arising from the ovary if the patient still has an ovary.Since the patient has had surgery apparently for hysterectomy it is conceivable that this could represent a hematoma.The density reading are higher than would be expected for a benign cyst.Finding did not appear to be present on the patient¿s previous ct dated (b)(6).Sterile abscess could also produce such a finding.Impression: smooth well-defined mass in the left iliac fossa measuring about 4 to 5 cm in diameter.The etiology is uncertain but the possibilities are discussed above.It is a new finding.Renal calculi.On (b)(6) 2003: (b)(6) diagnostic center.(b)(6) , md.Radiology-ct abdomen/pelvis without pelvis.Indication: abdominal pain.Findings: there is however evidence of a right parasagittal hernia lateral to the rectus sheath extending from the level of the anterior superior iliac spine to acetabulum.This however may represent a focal weakness in the musculature.This does contain bowel.In addition there is an apparent collection of small bowel and colon in the pelvis extending anterior to the pubic symphysis.This has a soft tissue rim suggesting adhesion or peritoneal reflection.This has the appearance of an internal hernia.It contains both small bowel and colon however it does not appear obstructed.Impression: status post cholecystectomy and hysterectomy.Stable nonobstructing right nephrolithiasis.Focal weakness versus hernia containing bowel in the right parasagittal region lateral to the rectus sheath.There is no evidence of obstruction.Possible internal hernia containing colon and small bowel extending over the anterior aspect of the pubic symphysis.This has a soft tissue rim which may represent a peritoneal reflection of adhesions.There is however no evidence of obstruction.Healing of the midline pelvic incision compared to (b)(6) 2003.Implant procedure: laparoscopic repair of ventral hernia with dualmesh.Implant: gore® dualmesh® [ni/ni, ni] implant date:(b)(6) 2003 (hospitalization [ni]).On (b)(6) 2003: (b)(6) medical health system.(b)(6) , md.Operative report.Preoperative diagnosis: recurrent ventral hernia.Postoperative diagnosis: same.Anesthesia: general by dr.(b)(6) and(b)(6) , crna.First assistant: (b)(6) , md.Second assistant: (b)(6), cfa.Estimated blood loss: 100 cc.Complications: none.Drains: none.Specimens: none.Disposition: recovery room stable.Preoperative diagnosis: i reviewed the preoperative informed consent discussion that i had previously held with ms.Roll and also her history and physical.I checked in with the patient to make sure that we were both satisfied to prepare for operation.We agreed at that point to proceed to the operating room.She received scds, heparin and vancomycin preoperatively and was taken to the operating room.Description of procedure: ¿the patient was placed on the operating table supine.After induction of general endotracheal anesthesia, a foley catheter was placed.Scds were placed.Dr (b)(6) placed a right internal jugular central venous line and her abdomen was prepped and draped sterile.I inserted an endopath bladeless trocar to enter the abdomen bluntly and began insufflating.I then placed a scope to find a large amount of omentum adherent to the abdominal wall and then placed under laparoscopic guidance, two more 5 mm trocars and began using electrocautery and sharp dissection of the takedown of the omentum.On taking down the omentum circumferentially, she was found to have a large, approximately 15 x 15 cm lateral recurrence of her hernia which was then measured and dualmesh was brought onto the field and trimmed to fit with a generous overlap on all edges.The mesh was then placed in and double rolls of tacks were placed all the way around the defect utilizing two more ports that had been placed under laparoscopic vision to have good visualization and good tacking in all directions.When the mesh was tacked down in all directions, it was again reexamined and found to be good place.The abdomen was reexamined and found to have no significant bleeding or other problems.The bowel was actually never encountered during the procedure.The small trocars were removed under laparoscopic vision to insure there would be no bleeding and then the large trocar was removed.All incisions were copiously irrigated and suctioned and closed with 4-0 vicryl subcuticular and washed and dressed sterile.The patient tolerated the procedure well without apparent complications.Anesthesia was reversed.She was awakened and taken to the recovery room for a stat portable chest x-ray for line placement.¿ relevant medical information: on (b)(6) 2005: [facility ni].(b)(6) , md.Office notes.Here for another wound check of her skin fistula.It has been slowly improving and seems to have leveled off.It has been treated here for the past eight months.Is fed up and demands that something be done about it.I have stressed that i think it looks fine and that any operation has a significant chance of making it worse, and she has certainly had plenty of wound complications already.Understands and insists on proceeding.History of cholecystectomy, hysterectomy, two children, ventral hernia status post repair x2 open and laparoscopic with multiple wound complications from both.Morbid obesity.Denies use of alcohol and tobacco.Exam: abdomen soft, non-tender, non-distended.Normal bowel sounds.No masses, hernias or hepatosplenomegaly.At the bottom of her pannus is a small draining wound.It has not changed significantly.Impression: i think things look fairly stable, but she would like to proceed.I discussed with her the possibility of complications such as infection, bleeding, making her wound problems worse.She understands and insists on proceeding.Will plan for wound revision in the near future.On (b)(6) 2005: (b)(6) medical health system.(b)(6).History and physical.Chief complaint: wound 2 ½ years.History of chole, hysterectomy, ventral hernia, morbid obesity.Exam: abdomen obese with wound.On (b)(6) 2005: (b)(6) medical health system.[signature illegible].Anesthesia record.Weight 293 lbs., bmi 55.History of hysterectomy, 2000; abdominal surgeries x5; hernia repair x3.Explant procedure: wound revision, wound opened, debrided, and re-closed.[nurse reviewer note: type of mesh not indicated].Explant date: (b)(6) 2005 (hospitalization [ni]).On (b)(6) 2005: (b)(6) medical health system.(b)(6) , md.Operative report.Preoperative diagnosis: skin fistula from previous mesh repair of multiply recurrent large ventral hernia.Postoperative diagnosis: skin fistula from previous mesh repair of multiply recurrent large ventral hernia.Procedure performed: wound revision, wound opened, debrided, and re-closed.Drains: none.Complications: none.Anesthesia: general by dr.(b)(6).Findings: small area of chronic mesh infections, small recurrent hernia.Disposition: recovery room, stable.Preop: i reviewed and updated the history and physical and informed consent discussion i previously held with the patient in the office.I examined her, interviewed, and checked with her to make sure she had no further questions.When we were both satisfied we made an agreement to proceed to the operating room.Description of procedure: ¿the patient was given preoperative heparin and antibiotics, taken to the operating room, placed on the operating table in the supine position.After induction of general endotracheal anesthesia scds were placed and her abdomen was prepped and draped sterile.I examined the wound.It is a small draining skin fistula from the lower most aspect of her abdomen where she has had a previous mesh infection from a mesh ventral hernia repair and she has known recurrent hernia, i replaced retractors and circumferentially incised the skin all the around the fistula and then placed clamps on the fistula tract and used cautery to dissect down to the depth of the tract.At its bottom most point i found that there was a small area of chronically infected mesh with sutures.I sharply excised the un-incorporated mesh and the sutures in this area.I copiously irrigated and suctioned and found no further evidence of chronic infection.I also found that during this dissection i made a small entrance into a small recurrent hernia sac.I explored this sac to find that it was empty sac at this time with no evidence of any bowel in the wall.At this point, because the patient has been carrying on with a multiply recurrent ventral hernia i made a decision not to repair it today but instead close the sac with 0 vicryl.I also copiously irrigated with antibiotic impregnated saline and closed the surrounding fascia around the fistula tract with 0 vicryl sutures.I copiously irrigated and suctioned with antibiotic saline and closed the skin loosely with two 0 nylon sutures and packed betadine soaked gauze in between with the plan to do wound dressing changes.The incision was washed and dressed sterile.The patient tolerated the procedure without apparent complications.Sponge, needle and instrument count was correct.Anesthesia was reversed and she was awakened, extubated and taken to recovery room in stable condition for planned discharge the same day.¿ relevant medical information: on (b)(6) 2005: (b)(6) medical health system.Intra-operative notes.Wound class: contaminated/dirty.Asa class: level 3.On (b)(6) 2010: (b)(6) hospital.(b)(6) , md.History and physical.Was originally seen in surgical clinic in 2007 with morbid obesity, large infraumbilical hernia, chronic wounds in the left mid abdomen, chronic smoking and borderline diabetes, was advised to contact university of louisville at that point for possible abdominoplasty and repair of the hernia simultaneously.She has lost about 100 pounds since that time and the panniculus along with the sinuses needed excised.The patient had 6 to 7 separate hernia repairs done initially laparoscopically done by open method and according to the patient; she had a mesh placed in the lower abdomen.A ct scan of the abdomen done in 2007 showed a large recurrent ventral hernia in the midline of the lower abdomen without any evidence of incarceration.This time the patient comes in having lost even more weight, has been having three separate areas of drainage in the lower abdomen over the panniculus.She has some discomfort from this, denies fever, chills, has been on antibiotics for this persistent drainage.History of obesity, borderline diabetes.Surgical history of cholecystectomy, laparoscopic incisional hernia repair, open incisional hernia repair, debridement of abdominal wall, hysterectomy.Weight 180 lbs.Exam: abdomen is soft with a large panniculus in the lower abdomen with three separate areas of sinuses one to the right of the midline, two in the left lower abdomen without any surrounding redness or foul smelling drainage.There is no tenderness.Impression: chronic abdominal wall sinuses, incisional hernia.Plan: at this time, removal of this panniculus at the sinuses is appropriate and this will be accomplished under general anesthesia.On (b)(6) 2010: (b)(6) hospital.[signature illegible].Anesthesia record.Smokes 1 pack/day.On (b)(6) 2010: (b)(6) hospital.(b)(6) , md.Operative report.Preoperative diagnosis: abdominal wall sinuses times 3.Prior repair of the abdominal wall hernias multiple with placement of mesh.Postoperative diagnosis: abdominal wall sinuses times 3.Prior repair of the abdominal wall hernias multiple with placement of mesh.Procedure: excisional abdominal wall panniculus with sinuses attached to the marlex mesh.Reduction and repair of large infraumbilical incisional hernia.Anesthesia: general.Complications: none.Surgery time: 2 hours and 15 minutes.Estimated blood loss: 300 cc.Fluid given: 1800 cc crystalloids.Clinical history: this 40-year-old white female who has had 6 to 7 incisional hernia repairs initially laparoscopically, then by open method with placement of mesh on multiple occasions has developed 3 separate sinuses drainage into the lower abdomen.The patient was morbidly obese 3 years earlier, now has successfully managed to lose weight down to 180 pounds.This has resulted in significant lower abdominal wall panniculus with these sinuses and i have advised the patient to have the panniculus including the sinuses excised.Her ct scan showed large incisional hernia and the plan was to reduce and repair the hernia at the same time.Description of the procedure: ¿after patient received satisfactory general anesthesia, the abdomen was prepped and draped in sterile fashion.An elliptical incision was marked in the lower abdomen in transverse fashion and after incising the skin and subcutaneous tissue, chronic scar tissue was separated from the abdominal wall until 3 sinuses tracts were seen leading to one of the meshes in the extraperitoneal area.And this mesh including attached sinuses was completely excised.A large hernia sac containing small bowel and cecum were encountered and after the hernia contents were reduced back into the abdomen, the hernia sac was excised.The peritoneum was then closed with interrupted 0 vicryl sutures and i have elected not to use any mesh because of clean contaminating nature of the case and i have utilized the patient¿s own fascia for suturing.0 proline [sic] sutures were used to close the fascia.Subcutaneous tissue was irrigated with copious amounts of saline and after a #7 jackson-pratt drain was placed at the bottom of the subcutaneous tissue, the external end was brought through a separate small opening and anchored to the skin with nylon suture.Subcutaneous tissue was approximated with interrupted 0 vicryl sutures and the skin incision was closed with staples.Xeroform and dry sterile dressing was applied and patient was transferred to recovery room in good condition.¿ on (b)(6) 2010: (b)(6) medical health system.(b)(6) , md.Pathology.Pathology#: (b)(4).Specimen: a.Abdominal wall with sinus.B.Hernia sac.Final diagnosis: a.Abdominal wall tissue: ulceration and micro abscesses.B.Hernia sac: no diagnostic abnormality.Gross: a.Received designated abdominal wall is an [illegible] 30.1 x 9.2 cm segment of pink and tan skin with three defects that are 1-1.3 cm.The specimen has been excised to a depth of 12 cm.Sections through the specimen reveal a 1 cm area of necrosis.Representative sections will be submitted as a1-a4.B.Received designated hernia sac are two fragments of pink and tan membranous tissue that are [illegible].No lesions are identified.Representative sections will be submitted as b1.Microscopic: a.Sections consist of skin with ulceration featuring acute and chronic inflammation which extends into the subepithelial tissue.Micro abscesses are noted in the deeper tissue as well.B.Sections consist of hernia sac and skeletal muscle with the hernia lined by a smooth flattened surface.On (b)(6) 2010: (b)(6) hospital.(b)(6) , md.Discharge summary.Admit date: (b)(6) 2010.Final diagnosis: large abdominal wall hernia with multiple sinuses, status post excisional abdominal wall sinuses with repair of the hernia.On the day of admission, the patient had excision of abdominal wall sinuses with abdominal wall panniculus with repair of large infraumbilical hernia under general anesthesia.Received preoperative antibiotic in the form of cleocin.Postoperatively the patient was admitted to the hospital for pain control, intravenous fluids, control of nausea, observation for bleeding and also another dose of postoperative antibiotic.Received morphine pca for pain control and zofran for control of nausea.Received 1 dose of cleocin after surgery.Postoperatively did remarkably well; the jackson pratt showed sanguineous drainage.The incision was clean and intact.Became ambulatory tolerated diet.The day after surgery the patient was eager to go home and was discharged to home in improved and satisfactory condition.On (b)(6) 2011: (b)(6) medical heath system.(b)(6) , md.History and physical.Presented to the emergency room with complaints of right lower quadrant pain and it was thought she had possible appendicitis.A ct scan of the abdomen and pelvic, however, revealed a fluid collection in a sinus fistula tract similar to the one she had in 2005.Her white count was slightly elevated and her sedimentation was slightly elevated so she was admitted for intravenous antibiotics and consideration for possible surgery should it be needed.History of cholelithiasis and methicillin resistant staphylococcus aureus.Surgical history of hysterectomy, cholecystectomy, multiple hernia repairs.She is a smoker.Exam: abdomen soft, nontender, nondistended.There is a large amount of scar tissue of anterior abdomen.There is no cellulitis, erythema or fluctuance.No hernias are appreciated.Impression: clinically, there does not appear to be an abscess.I think this likely is a fluid collection.I think we can try and manage this nonoperatively, especially since she has had so many previous surgeries.On (b)(6) 2011: (b)(6) medical heath system.(b)(6).Radiology-ct abdomen/pelvis.Indication: vomiting; right lower quadrant abdominal pain and fever.Findings: there are postoperative changes in the anterior abdominal wall from hernia repair.There is a midline ventral hernia in the lower abdomen just above the level of the pubis into which a loop of bowel extends, without evidence of obstruction or strangulation.There is a thick wall rim enhancing collection in the anterior abdominal wall superficial to the anterior abdominal wall musculature suspicious for abscess with maximum measurements of 7.2 cm transverse by 2.9 cm anterior posterior by 5.6 cm craniocaudal.There is subcutaneous fat stranding and overlying skin thickening in the right lower quadrant anterior abdominal wall.There is diastasis of the rectus abdominus muscles.There is a small fat-containing umbilical hernia.Impression: there are postoperative changes in the lower anterior abdominal wall from previous ventral hernia repair.There is thick-walled rim enhancing collection in the midline of the lower anterior abdominal wall, along the superficial aspect of the abdominal wall musculature, suspicious for abscess, measuring up to 7.2 cm in greatest diameter.There is stranding in the subcutaneous fat and overlying skin thickening in the anterior abdominal wall of the right lower quadrant.Midline ventral hernia in the lower abdomen, just above the level of the pubis without evidence of strangulation or obstruction of the loop of small bowel extending into the hernia.Previous cholecystectomy.Biliary ductal dilatation is similar to the previous study of 7/22/08.The appendix is visualized and appears normal.On (b)(6) 2011: o(b)(6) medical heath system.(b)(6) , md.Discharge summary.Admitted: (b)(6) 2011.Discharge diagnosis: fluid collection.Secondary diagnosis: multiple abdominal surgeries.Hospital course: has had multiple abdominal operations.In 2008, had a similar fluid collection underneath her skin.According to patient, this was treated by dr.(b)(6) county.Has since moved to (b)(6) and wants to get her care here.Had been previously operated by dr.(b)(6).Presented to the emergency room with complaints of abdominal pain, nausea and vomiting.On physical exam, she had evidence of cellulitis.A ct scan revealed a fluid collection in her complex wound consistent with either a or an abscess.Her white count at admission was 12,000 and we started her on some vancomycin.The following day her white count became normal.Was started on by mouth antibiotics.She had no fever or change in the physical exam of her wound.Was discharged home with the above followup and recommendations.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Manufacturer Narrative
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H6: updated health effect , h6: updated investigation finding , h6: updated investigation conclusions, h6: d17: appropriate code/term not available for ¿false claim¿.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.Through gore's investigation we confirmed the device was not a gore device.No further investigation is required at this time.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as a false claim.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the ifu further states, ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Based upon the information received, the device remains in the patient and was not available for evaluation.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect, h6: updated investigation finding, h6: updated investigation conclusions, h6: d17: appropriate code/term not available for ¿false claim¿, the investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.Through gore's investigation we confirmed the device was not a gore device.No further investigation is required at this time.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as a false claim.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the ifu further states, ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Based upon the information received, the device remains in the patient and was not available for evaluation.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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