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| Catalog Number |
1DLMC02 |
| Medical Device Problem Code |
Insufficient Device Problem Information (3190)
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| Health Effect - Clinical Codes |
Abscess (1690); Unspecified Infection (1930); Tissue Breakdown (2681)
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| Date of Event |
06/22/2019
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Type of Reportable Event
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Serious Injury
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Event or Problem Description
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It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2014 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2019 and (b)(6) 2019, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: bowel, colon, or omentum adhesions to mesh, seroma/abscess, bowell or colon resection, bowel, colon or other organ perforation, wound treatment/wound vac for 90+ days on (b)(6)2 014 - incisional hernia repaired with gore dual mesh.On (b)(6) 2019 - taken to emergency surgery for colonic perforation, old mesh and portions of colon removed.Mesh was densely adherent to the underlying viscera.During the lysis of adhesions a right retroperitoneal abscess was noted behind the terminal ileum.On (b)(6) 2019 - end colostomy creation and partial skin closure with packing.Additional event specific information was not provided.
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Additional 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: implant preoperative complaints: on (b)(6) 2014: (b)(6) medical centers.(b)(6) , md.Indications: ¿the patient is a 55-year-old male who underwent exploratory laparotomy for a foreign body with end ostomy.He then underwent an ostomy reversal.He has subsequently developed an incisional hernia just to the right of midline just above the umbilicus.He states that this is giving him a moderate amount of pain and has interfered with his work, therefore desires that it be fixed.The risks, benefits and alternatives were discussed with the patient who wishes to proceed.Consent is on the chart.¿ implant procedure: laparoscopic incisional hernia repair with mesh, lysis of adhesions greater than 1 hour.[implant: gore® dualmesh® biomaterial, 1dlmc02/10159112, 8 cm x 12 cm x 1 mm thick] implant date: on (b)(6) 2014 [hospitalization dates (b)(6) 2014] on (b)(6)2 014: (b)(6) medical centers.(b)(6) , md.Operative report.Assistants: (b)(6), md/res, pgy1/(b)(6) , md/res, pgy3.Preoperative and postoperative diagnosis: incisional hernia.Anesthesia: general.Estimated blood loss: 50 ml.Specimens: none.Findings: a 4 x 8 cm hernia, 8 x 12 cm dualmesh used for fixation.Procedure: ¿the patient was taken to the operating room and placed on the operating room table in a supine position.After induction of general anesthesia, the patient was intubated without difficulty.Perioperative antibiotics were given.The abdomen was clipped.The area was prepped and draped in a sterile fashion.A timeout was done to verify the correct procedure and patient.A 5 mm optiview trocar was placed in the right upper quadrant, feeling that this would be the area of least adhesions given that his previous ostomy was on the left side.Upon entering the abdomen, it was noted that there was a significant number of adhesions to the midline.These were bluntly taken down to allow us to place a second 5 mm trocar in the right flank, right lumbar area.Once this was done, we were able the [sic] use blunt dissection to further lyse adhesions and open a space in the right lower quadrant to place a third trocar.Once this was placed, we were able to use blunt and sharp dissection to take down the adhesions that extended along the patient's midline incision.There were a significant number of adhesions and some of which were tenacious.It took greater than 1 hour to completely lyse these adhesions.Once this was done, however, we did note a hernia approximately 4 x 8 cm just above the umbilicus and just slightly right of midline.The total size of this was marked out and 2 cm was added to each dimension in order to guarantee good coverage.This gave us the need for an 8 x 12 cm dualmesh.This dualmesh then had the 4 cardinal directions with suture placement in the mesh.This was done taking care to make sure that the smooth side was oriented towards the bowel.Once these 4 sutures were placed, the mesh was then placed in the abdomen through the 12 mm trocar in the right lower quadrant.The mesh was then rolled and oriented correctly.Once this was done, the sutures were then brought to the outside utilizing a transfascial suture passer.Once this was done, we were satisfied with our placement and tension on the mesh for which desufflated the abdomen slightly to take all the tension off of the abdominal wall to confirm placement of the mesh.Once this was done, these transfascial sutures were tied.The mesh was then tacked to the anterior abdominal wall with protacker and 4 additional 0 ethibond sutures were placed again utilizing the transfascial suture passer.Once we were certain of our fixation to the anterior abdominal wall, the abdomen was copiously irrigated with sterile saline.There was no further evidence of any bleeding.The 12 mm trocar was removed and utilizing the suture passer and 0 ethibond suture was placed to close the fascial defect.Once the trocar site was closed, we removed the remainder of the trocars under direct visualization from the abdominal cavity and the abdomen was allowed to desufflate.There were no complications.All counts were correct.It must be noted that prior to the start of the case a foley catheter was placed for bladder decompression.This foley was discontinued at the end of the case.I was present for all portions of this procedure.¿ on (b)(6) 2014: (b)(6) medical centers.Implant record.¿mesh hernia dual biomaterial oval goretex 8 cm x 12 cm x 1 mm¿.Model/cat no.: 1dlmc02.Lot no: 10159112.Action: implanted.Number used: 1.Manufacturer: w l gore assoc.Relevant medical information: none.Partial explant preoperative complaints: on (b)(6) 2019: (b)(6) medical centers.(b)(6), md.H&p.Chief complaint: ¿pain abdomen: abdominal pain onset 1500 today, states he is constipated, hx of hernia was pushing to use the restroom [sic] and felt ¿something rip¿ pt passed out on toilet and hit top right of head, ablet [sic] to stand and get into chair unaissted [sic] to call ems, started on baclofen and soma today.¿ history of present illness [hpi]: ¿(b)(6) is a 61 y.O.White male with medical history of diabetes mellitus not on medication, asthma, chronic back pain sciatica and muscle spasm on multiple cns suppressants, hyperlipidemia, history of colostomy, ex-smoker presents with chief complaint of syncope with fall resulting head injury.Complaint of feeling weird today after taking baclofen today.Patient states that he usually takes soma for his chronic back pain, but pharmacy was out today and so they substituted it with baclofen today.States that he took 10 mg around 3 pm and then another 10 mg around 6 pm, after which started feeling weird.He then decided to go use the bathroom as he hasn't had a bowel movement in over 4 days, but somehow passed out and woke up on the floor, and called 911.Patient noted injury to right forehead.Also complaint of abdominal pain started several days ago since his constipation started 4 days ago.Also complaint of cough without expectoration.In ed patient was slightly confused, with significant spasm of all 4 extremities.Ed provider performed rectal exam without significant abnormality.Adl/iadl: partially dependent, lives alone.¿ ¿significant imaging findings: ct chest, abdomen and pelvis without: conclusion: sigmoid anastomosis.Large extraluminal collection of air and fecal material superior to the anastomosis with absence of a roughly 2 cm visualized segment of wall of the sigmoid just proximal to the anastomosis, presumably perforated.Extensive retroperitoneal air extending superiorly to the posterior mediastinum level.Cholelithiasis incidentally noted.¿ review of systems: ¿gi: no nausea, no vomiting, no diarrhea, ++constipation, +abdominal pain.¿ physical examination: ¿gastrointestinal: ++ multiple scar, colostomy scar on llq, bowel silent abdomen, firm diffuse tenderness, ? rebound tenderness.¿ assessment & plan: ¿perforated sigmoid colon: a [assessment]: with straining and feeling of ¿something ripped¿ exam showed decreased bowel sound, rigid abdominal wall, has history of clolstomy [sic] with sigmoid anastomosis.¿ ¿p [plan]: npo, iv antibiotics with zosyn.Monitor in step down unit.Ivf.Surgery consulted.¿ ¿constipation: a: pass gas, no bm for 4 days.P: scheduled and as needed bowel regimen.Follow up ct abdomen and pelvis to rule out obstruction as history of colostomy and abdominal surgery.¿ on (b)(6) 2019: (b)(6) medical centers.(b)(6) , md.Faculty attestation: ¿i have confirmed the history and personally performed the physical exam as well as the assessment/plan in the resident note.I have reviewed the documentation of history and exam at this time, and agree with their findings and plan, as documented, except as noted.At the time i co-sign the note, i will have reviewed the complete note.Additional comments: altered mental status, likely polypharmacy.¿ on (b)(6) 2019: (b)(6) medical center.(b)(6) , md.Surgical consult h&p.Reason for consult: ¿sigmoid colon perforation.¿ hpi: ¿(b)(6) is a 61 y.O.Year old male with h/o ex-lap w/colostomy 2/2 foreign body removal (2012), colostomy takedown (2013), and laparoscopic ventral hernia repair with mesh in 2014 who presents to the hospital with ct scan concerning for perforation of sigmoid colon.Patient is poor historian given altered mental status at this time.Per chart review he passed out in bathroom while have difficult bowel movement.When he woke he called 911 and noted pain to his head and abdomen.In ed he was slightly confused and ct head obtained with no abnormalities.On abdominal imaging there was concern for perforated colon and therefore surgery service was consulted.¿ physical exam: ¿abdomen: soft, moderate tenderness to left lower quadrant without rebound or voluntary guarding.No palpable masses noted.¿ ¿61 year old male with significant past surgical history as noted above who presents with sigmoid colon perforation of unknown etiology.Patient will need emergent operative intervention, however, he is unable to make medical decisions at this time and there is no next of kin.We will proceed with implied consent.Nothing by mouth, iv fluids, antibiotics.Discussed with dr.(b)(6) , senior resident, and dr.(b)(6), attending surgeon.¿ on (b)(6) 2019: (b)(6) medical center -.(b)(6) , md.Indication: ¿this is a 61-year-old male who presented to the hospital on (b)(6) 2019 with severe suprapubic abdominal pain.Of note, he had a history of recurrent foreign body insertion into the rectum, leading to perforation of the sigmoid colon status post hartmann procedure in 2012, followed by colostomy reversal in 2013 and laparoscopic ventral hernia repair with mesh in 2014.The patient noted increasing abdominal distention and pain in that region.The patient presented with altered mental status, was found to have had a syncopal episode in the bathroom, underwent ct (computed tomography) abdomen and pelvis, which showed concern for a colonic perforation, so was taken emergently for surgery.¿ partial explant procedure: 1.Rigid proctosigmoidoscopy.2.Exploratory laparotomy.3.Retroperitoneal exploration with drainage of right retroperitoneal abscess.4.Extensive adhesiolysis greater than 2 hours.5.Partial explantation of abdominal wall mesh.6.Resection of perforation including prior colorectal anastomosis including proximal native rectum.7.Tap (transverse abdominis plane) block and temporary abdominal closure with abthera and greater than 50 cm2.Partial explant date: on (b)(6) 2019 [hospitalization (b)(6) 2019 on (b)(6)2019: (b)(6) medical center -.(b)(6) md.Operative report.Assistants: (b)(6) , md/res.(b)(6) , md/res.Preoperative diagnosis: perforated colon.Postoperative diagnosis: perforated colon.Anesthesia: general.Estimated blood loss: 150 ml.Specimens: 1.Partial explanted mesh.2.Colorectal anastomosis with proximal native rectum.Complications: none.Wound classification: findings: ¿1.Perforation of colon just proximal to the prior colorectal anastomosis with gross spillage of stool into the pelvis and retroperitoneum.2.Left ureter and gonadal vessels identified and preserved.3.Cocooned abdomen with dense adhesions.4.Right retroperitoneal abscess behind terminal ileum.5.Prior anastomosis just distal to the perforation.6.Jejunum and ileum part of abscess/perforation wall.¿ procedure: ¿after implied consent was obtained, the patient was taken to the operating room and placed in the lithotomy position.Timeout was performed in which all members of the operating team, as well as the correct patient and procedure were identified.Prior to induction of anesthesia, confirmation of bilateral lower extremity scds (sequential compression devices) were functioning and in place was performed.The patient received preoperative antibiotics prior to cut time.General anesthesia was then induced.The patient initially underwent rigid proctosigmoidoscopy, during which the patient was noted to have an amount of thin brown stool in the vault.Approximately 15 cm from the anal verge, it was noted the patient had significant stenosis for which the rigid proctosigmoidoscope could not be passed.There was no evidence of ulceration or perforation distal to this stricture, however, the concern was the patient likely had perforated proximal.The rigid sigmoidoscope was removed.The patient was then prepped and draped in standard sterile fashion.We performed a midline laparotomy incision with a #10 blade carried down with cautery.We encountered a significant amount of scarring consistent with the patient's history of mesh placement.We carefully entered the abdomen, incising through the mesh and the opening the mesh superiorly and inferiorly.The patient was noted to have a significant amount of adhesions that had cocooned the abdomen.This followed with an extensive lysis of adhesions over 2 hours until all the small bowel could be mobilized.During our exploration, we noted a large right retroperitoneal abscess behind the terminal ileum.We also noted likely a contained perforation in the area of the prior colorectal anastomosis with a large abscess to which the portions of the jejunum and ileum were adhered.These portion of jejunum and ileum appeared questionably viable; however, it may have been a large abscess rind attached to the wall, which obscured our examination of viability.Once the bowel was freed from adhesions, we entered the bowel from the ligament of treitz and the ligament of treves.We also assessed the ascending, transverse and descending colons, which were fairly unremarkable.However, the descending colon anastomosis to the superior rectum, we noted a significant amount of scar tissue in that region.Upon careful dissection, we noted a large perforation just proximal to the anastomosis at that region.This was thoroughly irrigated with sterile saline and suctioned.Once we had completed our dissection, we identified the left ureter and gonadal vessels were identified and preserved.Using a gia stapler, we stapled 2 cm proximal to the perforation and divided.We similarly did this distally with a curved contoured stapler and divided.I used prolene to mark the suture line of the superior rectum.The mesentery was taken down with cautery.The abdomen was then thoroughly irrigated with sterile saline.Specimen was removed and sent off the field.It was opened on the back table and noted that it contained the perforation, as well as the prior anastomosis.Again, we then thoroughly irrigated the abdomen with sterile saline.We reassessed those portions of the jejunum and ileum, which appeared questionably viable.Again, however, given the dense thick rind from the abscess cavity over the portion of the bowel, it was unclear if these were viable or not.We had also during our entry had explanted portions of the mesh in the midline, which appeared to be densely adhered to the underlying viscera.Given the questionable viability of the bowel, a decision was made at this point to leave the patient open in discontinuity for a second look laparotomy within 48 hours.We placed an abthera device over the abdomen and secured this in place.Suction was adequate at the end of the case.Overall, the patient tolerated the procedure well without complication.He was hemodynamically normal and off pressors throughout the case.At the end of procedure, all counts were reported correct.The patient was actually extubated successfully and taken to the pacu (postanesthesia care unit) in stable condition.(b)(6) , md was present and scrubbed for the entire procedure.¿ ¿disposition: the patient was extubated but kept open in discontinuity, given the possible involvement of the jejunum and ileum along the abscess cavity and the questionable viability for planned second look in 48 hours.¿ on (b)(6) 2019: (b)(6) medical center.(b)(6) , md.Operative report.Procedure: staged laparotomy, tapp block, mobilization of splenic flexure colon, end colostomy creation.Assistant: (b)(6) , md (resident).Preoperative diagnosis: open abdomen in discontinuity.Postoperative diagnosis: same.Anesthesia: general.Estimated blood loss: 25 ml.Specimens: none.Complications: none.Wound classification: findings: ¿recollection of contained interloop abscess.End colostomy creation.Skin partial closure with intermittent packing.¿ procedure: ¿after risks benefits and alternatives were discussed with the patient, informed consent was obtained.Patient was taken to the or suite and placed in supine position.Anesthesia was administered.The abdomen was prepped and draped in sterile fashion.Timeout was performed.The previous abthera was removed.The small bowel was ran from the ligament of treitz distally.The previous small bowel that formed the wall of the previous abscess appeared to reform a new interloop abscess that we opened and drained.The small bowel appeared viable.Next the area was irrigated.The colon was followed from the cecum distally.The appendix was normal.Adhesions of the omentum to the abdominal wall were taken down.Next the descending colon was mobilized off the white line of toldt.The splenic flexure was taken down using bovie cautery.There was a small 1 cm capsular tear off the inferior pole of the spleen that was controlled with surgicel.Next with the colon mobilized, the descending portion appeared to lay exactly where his previous ostomy was at.Therefore an ostomy site was made through his previous ostomy site.Bovie was used to remove skin and subcutaneous fat, a cruciate fascial incision was created and muscle splitting technique was used to enter through the rectus.The colon was brought through the ostomy site.Next the abdomen was irrigated.Tapp block was performed with ropivacaine in all four quadrants.Next the fascia was closed with two running pds sutures.The skin was loosely closed with staples.Next the ostomy colon was opened and brooked to mature the ostomy.Ostomy appliance was placed.The midline incision was packed.Patient tolerated procedure well.Dr.(b)(6) was present and scrubbed for the entire case.(b)(6) ,.¿ on (b)(6) 2019: (b)(6) medical centers.(b)(6) , do.Pathology report.Specimen: ¿1.Wall mesh.2.Descending colon, superior rectum.Clinical data: perforated colon.Final diagnosis: 1.Wall mesh: consistent with mesh material.2.Descending colon, superior rectum: segment of large intestine with perforation and adjacent mild ischemic changes.Focal abscess involving pericolic soft tissue.Acute serositis.Serosal adhesions.Negative for dysplasia and malignancy.Gross: 1.The specimen container is labeled with the patient's name (which has been verified) and wall mesh.It contains 2 portions of tan-white to tan-brown apparent mesh measuring 3.5 x 1.9 x 0.2 cm and 2.9 x 1.4 x 0.2 cm.The smaller tissue displays a 2.0 cm attached blue green suture.Also received separately in the container is a 1.8 x 0.1 cm silver metallic, curved staple.The specimen is sectioned, and representative sections are submitted in 1a.2.The specimen container is labeled with the patient's name (which has been verified) and descending colon, superior rectum.It contains a 9.1 cm in length and 3.4 cm in external diameter portion of colon and possible proximal rectum with a 7.5 cm central area of exposed lumen 2.4 cm from both margins (possible disruption/possible incision).The serosa is tan-pink, focally shaggy, and glistening.The specimen displays up to 3.4 cm of attached yellow-tan to tan-green partially necrotic adipose tissue.No other distinct areas of defect are grossly identified.A 7.8 cm end to end anastomosis line of staples is present 1.8 cm from 1 margin.The mucosa is tan-white to tan-pink and heavily edematous with partial loss of normal folding and no other masses or lesions.Representative sections are submitted as follows: 2a -1 margin, en face; 2b-margin nearest anastomosis, en face; 2c-2d-necrotic wall in area of defect and necrotic adipose tissue.¿ on (b)(6)2019: (b)(6) medical centers.Procedure: ct guided accordian drain placement x 2 (luq, llq).On (b)(6) 2019: (b)(6) medical centers.(b)(6) , pa.Discharge summary.Hospital course: ¿(b)(6) is a 61 y.O.Year old male with h/o ex-lap w/colostomy 2/2 foreign body removal (2012), colostomy takedown (2013), and laparoscopic ventral hernia repair with mesh in 2014 who presents to the hospital with ct scan concerning for perforation of sigmoid colon.Patient is poor historian given altered mental status at this time.Per chart review he passed out in bathroom while have difficult bowel movement.When he woke he called 911 and noted pain to his head and abdomen.In ed he was slightly confused and ct head obtained with no abnormalities.On abdominal imaging there was concern for perforated colon and therefore surgery service was consulted.6/25 s/p end colostomy replacement removal of mesh, partial closure of abd.Patient [sic] found to have intra-abdominal abscesses now s/p ir drain x 2 on 7/1.Wbc has normalized with abx.Patient is clear to d/c home with drains and remaining abx doses.He will have his brother at home to help.Patient has been educated on wound care, ostomy care, and drain care/flushes.He will discharge home with fww, hh wound and hh pt.Patient will follow up in tss clinic next week for wound and drain check.¿ ¿discharge exam: abdomen: soft non-tender.Midline incision loosely approximated with staples, open skin wounds packed with wtd dressings.Wound beds clean with pink granulation tissue.Ostomy to left abdomen with soft stool and gas in bag luo truclose drain with serosang output.Llq truclose drain with seropurulent output.¿ discharge instructions: ¿please make a follow up appointment with primary care physician within 14 days.Return to trauma surgery clinic next week (7/10 or 7/12) for wound and drain check.¿ ¿seen and discussed with attending provider dr.Long, andrea who is the physician of record.¿ see attachment.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.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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Additional Manufacturer Narrative
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H6: updated health effect.H6: updated investigation finding.H6: updated type of investigation.H6: updated investigation conclusions.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.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.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 instructions for use further warn: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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.A portion of the device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Based upon the information received, part of the device remains in the patient and was not available for evaluation.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.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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Additional Manufacturer Narrative
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H6: conclusion code remains unchanged.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.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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Search Alerts/Recalls
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