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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC

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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 1DLMCP04
Device Problem Insufficient Information (3190)
Patient Problem Hematoma (1884)
Event Date 04/15/2008
Event Type  Injury  
Event Description
It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2007 whereby a gore® dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2008, (b)(6) 2008, (b)(6) 2008, (b)(6) 2009 and (b)(6) 2009, additional procedures occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: small bowel obstruction; hematoma; adhesions; mesh infection; mesh failure resulting in hernia recurrence requiring placement of new mesh for repair; abdominal wall abscess requiring incision and drainage operation; fistula; small bowel perforation; small bowel resection; wound debridement; interval break of the mesh; herniation of the small bowel; pain. Additional event specific information was not provided.
 
Manufacturer Narrative
Product identification records for the alleged gore device were not provided. Therefore, a review of the manufacturing records could not be performed. 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) 2004: (b)(6) operative report. Preoperative diagnosis: morbid obesity. Postoperative diagnosis: morbid obesity. Operation/procedure: laparoscopic gastric bypass, 30 cc gastric pouch, 100 cm jejunal limb. ¿the patient was then awakened, extubated and taken back to the recovery room in stable condition. ¿ on (b)(6) 2005: (b)(6) history and physical. Patient had history of morbid obesity, for which she underwent roux-en y gastric bypass surgery on (b)(6) 2004, and lost approximately 130 pounds. Did well postoperatively until approximately 4-5 months ago when she began to complain of some persistent abdominal discomfort, as well as some nausea, vomiting associated with pain. Patient developed umbilical hernia, as well as gallstones, and both issues resolved surgically. Follow these surgeries patient continued to do poorly complaining of, again persistent pain, nausea and vomiting. Underwent ct which revealed findings consistent with possible malrotation of large bowel with cecum located in left upper quadrant of abdomen and single dilated loop of small bowel in right upper quadrant. Medication include prevacid. History of gastroesophageal reflux disease. Surgical history cesarean section in 1988, 1994, 1985; laparoscopic cholecystectomy in (b)(6) 2005, and umbilical hernia repair. Weight (b)(6), height 5 feet 4 inches. Exam: exhibit some mild tenderness in periumbilical area on deep palpation. No masses noted. Old incisions are well-healed. Plan: exploratory laparoscopy with intraoperative egd. On (b)(6) 2005: (b)(6) operative report. Operation/procedure: esophagogastroduodenoscopy. ¿the endoscope was withdrawn and the patient tolerated that [sic] the procedure well. Then the abdominal procedure was then started. ¿ on (b)(6) 2005: (b)(6) operative report. Preoperative diagnosis: abdominal pain. Possible partial small bowel obstruction secondary to internal hernia. Postoperative diagnosis: normal esophagogastroduodenoscopy. Partial small bowel obstruction secondary to petersen¿s hernia. Appendicitis. Incisional hernia. Operation/procedure: egd. Laparoscopy with adhesiolysis. Open laparotomy with repair of petersen¿s internal hernia. Appendectomy. Incisional hernia repair. Assistant: (b)(6). Anesthesiologist: (b)(6) description of operation/procedure: ¿the patient was taken to the operating room after being prepped and draped sterilely and given general anesthesia. Veress needle was inserted just above the umbilical region with negative pressure to the region and 3 l of c02 was then used to insufflate the peritoneal cavity. Once that was done, then a 5-mm right-side port had been inserted, another one inserted in the left upper quadrant region, one in the right upper quadrant region and another one in the left mid quadrant region. Once these are in place multiple adhesions are then encountered, and these are taken down. The abdomen is explored and it is noted that the ____ is coming down, and there is a twist within it¿s [sic] mesentery, so the cecum is then located. It is located in the left upper quadrant region, what appears to be in the internal hernia. Attempts were made to try and get this out. We could not get it out because it appeared to be attached to something, so we could not do this. A serosal tear was noted on the small bowel, and this was repaired laparoscopically with 3-0 gi silks. Three of these were used. After multiple attempts to again reduce the hernia, i was unable to do it, so i elected, now after about an hour and a half of attempting this, to open up the abdomen. The abdomen was converted to open, and it was noted that she had an incisional hernia on the bottom part of the incision approximately 6 x 6 cm in size. Once the abdominal cavity was entered then exploration was then done. It is noted that the cecum is stuck to the transverse mesocolon, but it is stuck there with the appendix. The appendix is firm and fibrotic and some inflammation is noted to the attachment on the transverse colon. This is what kept the cecum from being able to be removed from the internal hernia. An appendectomy was then performed by ligating the mesenteric vessels with 3-0 silk. Then the appendix was then doubly ligated with 0 chromic and then the appendix was doubly clamped and removed from the field. The stump was cauterized. The patient still had an internal hernia, and what i found was that almost the entire part of the small bowel, including the cecum, had gone through a petersen¿s hernia, and then this was successfully removed. The petersen¿s hernia defect was now obliterated by applying multiple sutures of 3-0 silk onto the small bowel mesentery and to the transverse colon. Thus, the defect was obliterated, and the bowel was then placed back in its normal position. The wound is now copiously irrigated. A piece of seprafilm was then applied onto the small bowel, and then the incisional hernia repair was then repaired by finding the bordered and removing the hernia sac. The defect was then closed using multiple and interrupted sutures of figure-of-eights of #1 prolene, and then the skin was closed with 4-0 monocryl. Sterile dressings were applied. The patient tolerated the procedure well and send back to recovery room in stable condition. ¿ on (b)(6) 2005: (b)(6) discharge summary. History: admitted with abdominal pain. Underwent egd and laparoscopy with adhesiolysis. Started out laparoscopically and had to be converted to open repair, as she had internal hernia. Also had incisional hernia which was repaired at the time. Postoperatively did well. Ambulatory, tolerated full liquids and taking oral pain meds. Discharged home in stable condition. On (b)(6) 2005: (b)(6) operative report. Preoperative diagnosis: incidental carcinoid tumor. Postoperative diagnosis: incidental carcinoid tumor. Operation/procedure: right hemicolectomy. ¿the patient tolerated the procedure well and was sent back to the recovery room in stable condition. ¿ on (b)(6) 2006: (b)(6) discharge summary. Admission date: (b)(6) 2005. Discharge date: (b)(6) 2006. This patient had incidental findings of carcinoid tumor. Brought back and underwent right hemicolectomy. Postoperatively, did remarkably well. Final diagnosis: incidental carcinoid tumor finding. On (b)(6) 2006: (b)(6) operative report. Preoperative diagnosis: small bowel obstruction. Multiple incisional hernias. Postoperative diagnosis: small bowel obstruction. Multiple incisional hernias. Operation/procedure: exploratory laparotomy with reduction of the small bowel obstruction and repair of an internal hernia mesenteric defect. Repair of multiple incisional hernia. Assistant: (b)(6) anesthesiologist: (b)(6) description of operation/procedure: ¿the patient was taken to the operating room and placed in the supine position. After being prepped and draped sterilely and given general anesthesia, an incision was made in the midabdomen and carried down to the end of the abdominal cavity. Along the opening there are multiple incisional hernias, anywhere from 2-4 cm in size. Once we entered the abdomen the balfour retractor is applied. Exploration reveals that there is a mesenteric defect in which approximately 12 inches of small bowel is trapped. This is gently removed from the mesenteric defect and thus the obstruction is relieved. The inspection of the roux limb is then done. The jejunojejunostomy and the entire small bowel is otherwise unremarkable. This patient had previous carcinoid tumor found in the appendix and there is no evidence of recurrence. The mesenteric defect is now closed with a running suture of 2-0 ethibond. No other findings are found at this time. Closure and repair of the incisional hernia is then done. The fascia is ___ delineated and a running suture of #1 prolene is then applied, one from below, one from above; thus, obliterating the hernia defects. There are no other findings at this point. The wound is anesthetized and closure of the wound is done using 2-0 vicryl in subcutaneous tissue, and 4-0 monocryl on the skin. Sterile dressings are applied. The patient tolerated the procedure well and was sent back to the recovery room in stable condition. ¿ on (b)(6) 2006: (b)(6) discharge summary. Admission date: (b)(6) 2006. Discharge date: (b)(6) 2006. History: patient admitted for partial bowel obstruction. Taken to surgery on (b)(6) and underwent repair of small bowel obstruction. She had internal hernia and multiple incisional hernias, which were repaired. Postoperative day 1 she was ambulating well. Her nasogastric tube was minimal and so it was removed. By the 5th she was tolerating some liquids; however, she had no flatus. Her abdominal exam removed [sic] clean. By (b)(6) she was doing well. Wounds were well healed and she was able to tolerate a diet without difficulty. Discharged home in stable condition. Return to office in 1 week. Final diagnosis: partial bowel obstruction, incisional hernia. Implant procedure: repair of an incisional hernia using tool mesh. Adhesiolysis. Implant: ¿dual mesh of 8 inches x 6 inches in size¿¿ [no implant record available for review] implant date: (b)(6) 2007 (hospitalization (b)(6) 2007). On (b)(6) 2007: (b)(6) operative report. Preoperative diagnosis: status post gastric bypass. Partial small bowel obstruction. Recurrent incisional hernia. Status post removal of carcinoid tumor. Postoperative diagnosis: status post gastric bypass. Partial small bowel obstruction. Recurrent incisional hernia. Status post removal of carcinoid tumor. Operation/procedure: repair of an incisional hernia using tool mesh. Adhesiolysis. Assistant: diane barns, md. Anesthesia: general. Description of procedure: ¿the patient was taken to the operating room and placed in the supine position after being prepped and draped sterilely and given general anesthesia. The incision was made in the midline and it was carried down into the abdominal cavity. Adhesions were encountered and these were taken down sharply. A hernia sac was also found and then removed. This left a defect of approximately 8 inches x 4 inches in size and so a piece of dual mesh of 8 inches x 6 inches in size was then applied and anchored with a gore-tex suture all over the lateral edges. It was finally secured into good position. It was tension free. There was no bleeding. The wound were then copiously irrigated with antibiotic solution and then the skin was reapproximated using 3-0 vicryl in interrupted fashion and then the skin was closed using 4-0 monocryl. Sterile dressings were then applied and double binders applied. The patient was then awakened, extubated and taken back to the recovery room in stable condition. ¿ relevant medical information: on (b)(6) 2007: (b)(6). Radiology- ct abdomen/pelvis. Indication: status post anterior abdominal wall hernia repair, presents with drop in hematocrit. [findings and impression not provided; page 2 of report not provided]. On (b)(6) 2007: (b)(6). Discharge summary. Admission date: (b)(6) 2007. Discharge date: (b)(6) 2007. History of presenting illness: patient underwent incisional hernia repair with large piece of mesh applied. Tolerated procedure well. Abdomen was soft and nontender on postoperative day 1 and she started on clear liquids. However, on following day, her abdomen became distended. Midline wound became a little tender. Had no bowel sounds. Given suppository to help pass gas. H&h dropped to 5 and 15 and her midline abdominal wound was now intense and became bruised. It was felt she had a bleed into the wound and so she was given transfusion. Ct scan revealed she had bled into the wound and had a hematoma. Abdominal incision remained unremarkable and did not change. We felt she was safe to go home. We felt that we would not like to drain this because of the mesh underneath and we wanted to avoid infection, so she was sent home on pain medication and antibiotics. Return to office in 1 weeks¿ time. Diagnosis: incisional hernia. On (b)(6) 2008: (b)(6). Operative report. Preoperative diagnosis: partial small bowel obstruction. Postoperative diagnosis: partial small bowel obstruction. Operation/procedure: exploratory laparotomy with adhesiolysis for partial bowel obstruction. Assistant: (b)(6). Anesthesiologist: (b)(6). Description of operation/procedure: ¿the patient is taken to the operating room, placed in supine position. After being prepped and draped sterilely and given general anesthesia, an incision is made in the midline and carried down to the abdominal cavity. There is an old hematoma, which is irrigated and removed. The mesh is then opened up and the abdomen is then entered. There is a capsule from the mesh. On the capsule on the anterior surface there are multiple loops of small bowel they are adherent to this region causing the partial bowel obstruction. The adhesions were taken off the old capsule and with a segment of approximately 1 foot of small bowel that was in this area. The rest of the small bowel was then explored and was unremarkable. The gastrojejunostomy is noted and is unremarkable. The roux limb is also followed down to the jejunojejunostomy, which is patent. The biliopancreatic limb is normal and then the bowel is followed all the way down to the ileocecal junction, which is unremarkable. The ileo to colon anastomosis was also noted to be normal. This large bowel does have multiple stools, but is otherwise negative. The wound is now irrigated copiously. No other findings. Closure of the abdomen is then done using #2 prolene in the fascia including the dual mesh. No other findings are noted. After correct lap and instrument counts, then closure is done. The subcutaneous tissue is closed using 2-0 vicryl, then 4-0 monocryl on the skin. Sterile dressings were applied. The patient tolerated the procedure well and sent back to the recovery room in stable condition. ¿ on (b)(6) 2008: (b)(6). Radiology- ct abdomen/pelvis. Indication: abdominal pain. Impression: interval break of the mesh in the anterior abdominal wall on its superior aspect with a herniation of the small bowel. No evidence of bowel obstruction. Small seroma in the surgical site. Clinical correlation is recommended. On (b)(6) 2008: (b)(6). History and physical. This is a (b)(6) female who has a long history of having had multiple abdominal surgeries. Has had a previous gastric bypass. She also had colon resection for carcinoid tumor, and a couple surgeries for incisional hernias. Comes into the office with history of abdominal pain and drainage from wound. This obviously was a wound infection that is giving her problems. Given antibiotics and _____ clean it up, but ct scan reveals disruption of repair and drainage continues. She has been brought in for removal of infected mesh and repair of hernia with possible biologic tissue. Exam: abdomen reveals some drainage from midline area. Impression: recurrent incisional hernia; infected mesh. Explant procedure: removal of the infected mesh, repair of recurrent incisional hernia using veritas biologic mesh. Explant date: (b)(6) 2008 (hospitalization unknown). On (b)(6) 2008: (b)(6). Operative report. Preoperative diagnosis: recurrent incisional hernia, infected mesh. Postoperative diagnosis: [left blank]. Operation/procedure: removal of the infected mesh, repair of recurrent incisional hernia using veritas biologic mesh. Assistant: (b)(6). Anesthesiologist: (b)(6). Description of operation/procedure: ¿the patient was taken to the operating room and placed in supine position. After being prepped and draped sterilely and given general anesthesia, incision was made in the midline and carried down to the abdominal fascia. This was opened up and there indeed is infection of the old mesh. This was cultured. The wound was irrigated thoroughly. The mesh was now removed from the area and once it was completely removed, the area was then copiously irrigated with antibiotic solution. There was no intraabdominal infection and some of the adhesions were taken down. Once that was accomplished, a biologic piece of mesh called veritas was introduced and this was then used to repair the abdominal wall defect. The edges were well identified and then using suture of #1 prolene, this was then used in running fashion on both sides to completely apply the biologic mesh. It was in good condition with no tension. The wound was again irrigated thoroughly with antibiotics solution. The subcutaneous tissue was closed with 3-0 vicryl and 4 0 monocryl on the skin. Sterile dressings were applied. The patient tolerated the procedure well and was sent back to the recovery room in stable condition. ¿ there is no mention of gore device removal in the records. Relevant medical information: on (b)(6) 2008: (b)(6). Pathology. Diagnosis: ventral hernia. Specimen source: abdominal mesh. Gross exam: received in formalin labeled ¿abdominal mesh. ¿ it consists of two gray-tan to light brown abdominal mesh, 15 x 4. 0 x 0. 3 cm and 16 x 4. 5 x 0. 3 cm. The periphery of the large portion contains white sutures. Representatives sections submitted in one cassette. Microscopic exam: macroscopic examination performed. Diagnosis: abdominal mesh: retractile synthetic abdominal mesh with foreign body type giant cell reaction and acute inflammation. Comment: cultures are in progress. On (b)(6) 2009: (b)(6). Office notes. Still having drainage from wound. (b)(6), height 64, bmi 32. 71. Exam: wound is healing no erythema a few gaps in the incision without much drainage. Plan: start clindamycin and percocet. On (b)(6) 2009: (b)(6). Pathology. Diagnosis: abdominal wound dehiscence. Specimen source: abdominal mesh. Gross exam: received in formalin labeled removed abdominal mesh. It consists of a white-tan to light brown synthetic mesh material, measuring 14. 0 x 4. 5 x 0. 3 cm. No gross abnormalities are seen. Representative sections are submitted in one cassette. Diagnosis: abdominal wound closure: infected prosthetic allograft. Comments: cultures are in progress. On (b)(6) 2009: (b)(6). Office notes. Here for wound recheck. (b)(6), height 64, bmi 31. 58. Exam: wound is clean no drainage. Plan: return in one week to remove staples. On (b)(6) 2009: (b)(6). Office notes. Wound check, staple removal. Exam: midline incision with staple note and 3 areas of superficial wound dehiscence and minor purulent drainage noted along lower aspect; staples removed completely, and open areas probed with sterile homestat and found to be superficial and not tracking. Impression: postoperative wound infection, superficial wound dehiscence with infection. Plan: daily dressing changes with wet to dry dressings. Bactrim after 10 days. On (b)(6) 2009: (b)(6). Office notes. Infection. Exam: wound is almost healed smells of a yeast infection. Impression: ventral hernia. Yeast infection. Plan: start diflucan. On (b)(6) 2009: (b)(6). Office notes. Nausea, vomiting, diarrhea for one day now; abdominal pain. Exam: tender to lower abdomen; low midline incision healing with infection improving and no evidence of hernia, no guarding or rigidity, no masses felt. Plan: ct abdomen/pelvis. On (b)(6) 2009: (b)(6). Alexander alan. Radiology- ct abdomen/pelvis. Indication: abdominal pain. Impression: there appears to be a phlegmonous process with possible abscess in the midline of the anterior abdominal wall at the site of some type of previous abdominal surgery. On (b)(6) 2009: (b)(6). History and physician. (b)(6) female who comes in with history of having abdominal pain. Being admitted through the emergency room. Onset of abdominal pain for past couple of days. Previous laparoscopic gastric bypass for weight loss surgery approximately 3 to 4 years ago. This resulted in her then coming back and having a partial small bowel obstruction, at which times a large appendix was removed, and this revealed a carcinoid. Came back to have extended right hemicolectomy for that surgery. She then had multiple incisional hernias, the last one being repaired earlier in the year with placement of mesh. That subsequently got infected and had to be removed and was primarily closed approximately 3 weeks ago. Followed up in office for some drainage from the wound. Had been on antibiotics, but did not seem to help. An abdominal ct was done which revealed an inflammatory area in lower part of incision. Admitted with intravenous antibiotics and possible drainage. She does not smoke or drink. Exam: 2 areas that are slightly open with minimal drainage. Area is tender to touch. On (b)(6) 2009: (b)(6). Operative report. Preoperative diagnosis: abdominal wall abscess. Postoperative diagnosis: abdominal wall abscess. Operation/procedure: incision and drainage of a 4 x 6 cm abdominal wall abscess. Assistant: (b)(6). Description of procedure: ¿the patient is taken to the operating room. After being prepped and draped sterilely and given general anesthesia, an incision was made down on the lower abdominal part of the incision, carried down approximately 3 to 4 cm deep and there was an abscess cavity which was then irrigated and drained and debrided. Cultures were taken of this. Once that is done, after the area is copiously irrigated with antibiotic solution, it is now packed with antibiotic-soaked 4 x 8¿s. Sterile dressing were then applied. She was then awakened, extubated and taken back to recovery room in stable condition. ¿ on (b)(6) 2009: (b)(6) history and physical. Presented today for wound care but also secondary to findings of excessive drainage of particulate matter from her incision. This was found to have food particles draining from her midline incision and this it was obvious that she is have a communicating fistula between her intestine and her skin. In light of the finding she was admitted to the medical/surgical floor for evaluation. On (b)(6) 2009: (b)(6). Operative report. Preoperative diagnosis: enterocutaneous fistula. Wound infection. Postoperative diagnosis: enterocutaneous fistula. Wound infection. Operation/procedure: exploratory laparotomy with a small bowel resection. Debridement of the wound. Assistant: (b)(6), medical student. Anesthesiologist: (b)(6). Description of operation/procedure: ¿the patient was taken to the operating room. She was placed in the supine position. After being prepped and draped sterilely and given general anesthesia, an incision is made in the midline and carried down through the old pds sutures. Once the abdomen is entered, the small bowel that has the perforation and fistula come into the wound is then located. The abdomen internally was adhesion free and so that segment of bowel was brought up that had the perforation. It is approximately 1 cm in diameter. So then the bowel is brought up out of the wound using the gi stapler with the blue staples. This is fired proximally and distally to where the opening is, and then that segment is resected and removed. A stay suture of 3-0 silk is then applied to those 2 ends of the bowel and then side to side anastomosis is then done again by application of another gi stapler using the blue staples. Once small openings were made in the small bowel, the stapler is then introduced into those openings and the device is now fired and removed. There is no bleed along the staple line. So then that opening is then sutured closed with multiple interrupted sutures 3-0 silks as well the mesentery is also closed with 3-0 silks. This makes a new anastomosis in a side-to-side fashion, approximately 3. 5 cm in size. There is no ischemia. No bleeding. No tension on the anastomosis. So it is now placed back into the abdominal cavity. The wound is then irrigated with antibiotic solution and then closure of the midline incision is done with multiple interrupted sutures of #1 prolene. The area is anesthetized with 0. 25% marcaine. Approximately 20 ml is used. Then the skin is closed with staples, and packing is used into the wound where the prior infection was at. Sterile dressing was then applied. She is then awakened, extubated, and taken back to recovery room in stable condition. ¿ on (b)(6) 2009: (b)(6). Discharge summary. Admission date: (b)(6) 2009. Discharge date: (b)(6) 2009. History/hospital course: came in because he had a previous incisional wound abscess, which was opened up, approximately 4-5 days ago. She came back to clinic and now she was draining bile from her midline wound. So, it was suspected that the patient had enterocutaneous fistula. She was admitted, started on total parenteral nutrition and cone she was stabilized from that, she was taken to surgery on (b)(6) 2009. Tolerated procedure well postoperatively. Started on liquids postoperative day 2. Tolerated these, total parenteral nutrition weaned off. Wound remained clean and healed well, as we left that one area where the wound was opened. Discharged in stable condition. Return to office in 1 week time. Final diagnosis: enterocutaneous fistula. On (b)(6) 2009: (b)(6). Office notes. Status post small bowel resection now doing better at home with wound changes. Exam: open wound approximately 3 x 4 inches in size. Impression: open wound but healing. Plan: start percocet. On (b)(6) 2009: (b)(6). Office notes. Severe episode of diffuse abdominal pain yesterday, described as ¿crampy, gassy¿ with associated nausea, vomiting, diarrhea. Went to emergency department yesterday and was released in stable condition. Doing well and problems have resolved completely. Exam: very mild incisional tenderness; midline incision open at inferior aspect and noted to be healing well, with good granulation and no evidence of infection. Impression: gastroenteritis versus food poisoning. On (b)(6) 2009: (b)(6). Office notes. Follow up from surgery. Midline incision healing well and without evidence of infection. Drainage very minimal serous drainage from 1 cm superficial opening to lower aspect of midline incision. (b)(6), height 64, bmi 31. 75. Impression: chronic pain syndrome. Plan: referral to on (b)(6) for evaluation and management of chronic narcotic dependence. Continue with wet to dry dressings until midline incision completely healed. 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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Brand NameGORE® DUALMESH® BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
megan reigh
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key12642649
MDR Text Key281171355
Report Number3003910212-2021-01301
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2010
Device Catalogue Number1DLMCP04
Was Device Available for Evaluation? No
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2007
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/15/2021 Patient Sequence Number: 1
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