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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
Model Number 1DLMC04
Device Problem Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Obstruction/Occlusion (2422)
Event Date 11/09/2007
Event Type  Injury  
Manufacturer Narrative
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant #1 preoperative complaints: no information. Implant #1 procedure: epigastric hernia repair. [implant: gore® dualmesh® biomaterial, 1dlmc03/03349991, 10cm x 15cm x 1mm thick, oval]. Implant #1 date: (b)(6), 2005 (hospitalization dates unknown). On (b)(6) 2005:(b)(6) hospital. (b)(6), md. Operative report. Preoperative diagnosis: incarcerated epigastric hernia. Postoperative diagnosis: two incarcerated epigastric hernias. Anesthesia: general. Estimated blood loss: none. Complications: none. Findings: ¿about 5 x 5cm midline defect above the umbilicus and then a 1cm defect above that. Bowel was entrapped. ¿ procedure: ¿with the patient under adequate general anesthesia, prepped and draped in the usual sterile fashion, a midline incision of the length of about 4cm was made above the umbilicus. The incision was carried down through the subcutaneous tissue until the hernia sac was encountered. The bowel was incarcerated in it. It was reduced. The fascial defect was identified. Investigation of the midline above the area of the defect revealed another 1cm hole in the midline in the fascia so the defects were joined together and then a gore-tex graph was sewn to the edges of the fascia using 2-0 prolene sutures in a running fashion; one for the right side and one for the left side of the defect. The result was satisfactory. The subcutaneous tissue reapproximated with 4-0 vicryl sutures and the skin was closed subcuticular interrupted sutures in 4-0 vicryl and steri-strips. The patient tolerated the procedure well and left the operating room in good condition. ¿ on (b)(6) 2005: (b)(6) hospital. Implant sticker. ¿dualmesh biomaterial. ¿ lot: 03349991. Item: 1dlmc03. Revision #1 preoperative complaints: on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Chief complaint: hernia. ¿he would like to get his hernia checked again, had surgery on it last year, but thinks that it may be coming back. It bothers him sometimes, but he is able to reduce it mostly, but doesn't seem to be able to do it all the way. He had trouble with cellulitis after the mesh hernia repair last year, so he is somewhat hesitant to consider it yet, but understands the risks of incarceration. He is willing to have his wife learn how to reduce it. He is continue [sic] to lose weight, so maybe we can get it down enough so that he does not need surgery. ¿ abdominal exam: ¿abdomen is obese. Palpation is ventral hernia - reduced. Small, approximate finger-tip or 1cm opening palpable in the fascia just above the umbilicus under part of the surgical vertical scar. ¿ assessment: recurrent ventral incisional hernia. Plan: will teach his wife how to do this next week to keep it reduced. Wants to defer surgery until he has more weight loss. Continue to look for incarceration. On (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Chief complaint: ¿patient brings in his wife today to see if we can teach her how to reduce his recurrent umbilical hernia at home. It recurred after he walked out the door with me last week after i reduced it. It does cause him some discomfort and some mild nausea, though he states he can live with it at this point. The area where the mesh is, is now protruding and he states it looks ¿like a baboon¿s hind end¿ with the way it protrudes. He is worried about it and ready to do something about it. He continues to lose weight. ¿ abdomen: ¿obese. When he stands, there is a bilobar bulbous prominence above the umbilicus, one on each side of the midline. On lying, the hernia is palpable and both i and his wife are able to reduce it, though it comes back out almost immediately even without the patient standing up. ¿ assessment: ventral incisional hernia, recurrent and worsening. Plan: ¿this is worse than when i saw him last week, so i called dr. (b)(6) and she will see him soon. ¿ scheduled to be seen in 3-7 days, though he was reminded of incarceration symptoms in which case he should get to an emergency room. On (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: incisional hernia. He has a large incisional hernia. I repaired that in 2005 and he developed an infection. So i am not surprised that it is recurrent. I am surprised that it took this long to actually show up. He smokes and he is on aspirin so we will do a quick smoke reduction and take the aspirin away for a little while and repair it on (b)(6) 2007. ¿ on (b)(6) 2007: (b)(6) hospital. (b)(6), md. History and physical. (b)(6) white male with incisional hernia. Abdominal exam: large incisional hernia. Impression: incisional hernia. Plan: repair. Revision #1 procedure: repair of double incisional hernias. Revision #1 date: (b)(6), 2007 (hospitalization dates (b)(6), 2007). On (b)(6) 2007: (b)(6) hospital. (b)(6), md. Operative report. Preoperative and postoperative diagnosis: incisional hernia. Anesthesia: spinal. Estimated blood loss: 100 cc. Complications: none. Specimens: none. Drains: 2 jackson-pratt drains in the subcutaneous tissue. On-q. Findings: ¿both sides of the prior repair where it is erupted and the left side had a fairly large (about 5 inches in diameter) hernia and a similar hernia only smaller was present on the right side. ¿ procedure: ¿with the patient under adequate spinal anesthesia, prepped and draped in the usual sterile fashion, the old incision was reopened all the way down to the subcutaneous tissue until the hernia sack on the right side was identified. It was freed from its adhesions to the omentum and to the subcutaneous tissue until the right edge of the fascia was identified. Following that, the remaining adhesions to the left side of the defect new hernia sack were taken down and they were all omental. Then the sacks were completely removed. This left a defect of a size of 10 cm x 10 cm where the fascia edges were completely cleaned with 0 prolene interrupted mattress sutures interspersed with simple sutures were used to reattach the new gortex mesh to the edges of the healthy fascia. Two round jackson-pratt drains were left in place and double on-q was placed in the subcutaneous tissue also. The skin was closed with interrupted subcuticular sutures and dermabond. The patient tolerated the procedure well and left the operating room on good condition. ¿ on (b)(6) 2007: (b)(6) hospital. (b)(6), rn. Discharge note. Discharged to home. Relevant medical information: on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: follow-up incisional hernia repair. The cultures from the drain removal show two types of coagulase negative staphs, both sensitive to doxycycline, both resistant to levofloxacin, so i had to give him a dose of doxycycline for about 7- 10 days. I will see then again on thursday. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post repair of incisional hernia. ¿he grew two different bacterias resistant to levaquin and sensitive to doxycycline so i put him on a seven days course of doxycycline. He started two days ago. He still has a little bit of clear exudate coming from the middle of his incision, but there is not redness anymore and the tissue seems rather solid, so hopefully the infection is just limited to the area under the incision. It does not look like it is generalized at this time. I will see him again on thursday. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post repair of incisional hernia. ¿he is still putting out about 10 cc per day of serous clear fluid. There is no evidence of cellulitis. I am trying to pack the tube and put the pressure dressing on the bottom part of his wound because there is slut this little pocket where there is a collection of clear fluid that drains every morning and every night when he changes his dressing. I will see him again in the middle of the month. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post incisional hernia repair. ¿he looks good and better. His incision is healed, but he still has a low-grade infection in one small area in the middle of the incision and there is a communication with the mesh going toward the left side of the incision. I am going to pack it with betadine-soaked iodoform gauze as a local and only way to eradicate that infection. If it does not disappear, the whole operation is in jeopardy. I will see him again on monday. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post incisional hernia repair. ¿he is almost completely healed but through that small opening the mesh is showing. It is a defect about the size of a quarter and so we will put betadine soaked gauze on it to make sure it does not get infected. In the meantime, hopefully the healing process will close the underlying area. I will see him again on monday. ¿ on (b)(6) 2007: office not indicated. (b)(6) , md. Office visit. Diagnosis: status post incisional hernia repair. ¿he still has a tiny, tiny little opening in the middle of his incision. I put some steri-strips on it, trying to decrease the tension and hopefully it will seal over. I will see him again on thursday. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post incisional hernia repair. ¿after i steri-stripped the area, actually there is quite a bit of granulation tissue growing around the opening. There is no purulence, it is just like a little serum coming out and i think we are making some headway, but i will see him again on thursday. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post repair of incisional hernia. ¿the small opening in the middle of the incision now is shallow. There is still some minuscule amount of serum coming out of it, but i cannot see the mesh underneath it any longer. The opening is smaller, so i think it will take another couple of visits before it closes completely. There is no evidence of infection or detachment of the repair at this time. I will see him again in two weeks. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post incisional hernia repair. ¿i have come to the conclusion that he has a small smoldering low grade infection right in the center of that incision and it grew staph aureus non mrsa, so i'm going to give him some bactrim ds since he is allergic to penicillin and probably to keflex as well and i will see him again on monday. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post incisional hernia repair. ¿he is almost all closed and i have been saying this for months, but there is a very small amount of drainage and i cannot even see the opening. So, i will see him again in two weeks and by then hopefully it will be closed. The trial of antibiotics i gave him for one week really did not help much. So i do not know if there is a low grade infection there which is worrisome or if it is just the area is right in the middle of the mass and there is a thin layer of skin there and it is really hard for it to close. I do not want to put a suture or clip there for fear of closing in infection so i am letting it heal from inside out. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post incisional hernia repair. ¿he still has some leakage of clear fluid so i put dermabond in his less than 1 mm opening. There does not appear to be any infection so i figured i might as well close it. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post repair of incisional hernia. ¿i still saw the smallest amount of mostly thick yellowish, creamy material coming out from this tiny little hole. There is a minimal amount, just a dot. So it is getting better and getting there, but the dermabond just did not stick for very long and he will see me again in two weeks. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post incisional hernia. ¿i freshened the edges of the opening which is a hairpin size, but in between poor blood supply and probably presence of a foreign body, it is not closing, so i closed it with 3-0 prolene sutures, one on each side of the opening. I do not expect it to stay together, but if it does, that would be great. 1 will see him again on thursday and if it is not staying together, i will probably need to excise that area and close it primarily. ¿ (b)(6) 2007: office not indicated. (b)(6), md. Acute office visit. Diagnosis: surgical incision. ¿had surgery in july and its still healing. Today there is a yellowish liquid sipping [sic] out. Dr. (b)(6) [sic] performed the surgery. Has an appt with her on this thursday [sic]. Has not worsened since then. ¿ exam: abdomen: ¿abd wound is open, reaction to tape surrounding, having some drainage, per patient, has been the same long term. ¿ follow up with dr. (b)(6). On (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: failure to heal in midline abdominal incision. That area is not healing and it has poor blood supply so i am going to have to put a small flap in there from the surrounding area and move it across and close it that way and take the tension away from that spot. I will do that on friday, (b)(6), 2007. ¿ on (b)(6) 2007: (b)(6) hospital. (b)(6), md. History and physical. ¿(b)(6) white male status post repair of incisional hernia. Has a skin dehiscence. ¿ abdominal exam: open central area. ¿impression: wound dehiscence. Plan: flap repair. ¿ on (b)(6) 2007: (b)(6) hospital. (b)(6), md. Operative report. Scar revision, closure. Preoperative diagnosis: non-healing wound, status post incisional hernia repair. Postoperative diagnosis: subcutaneous fistula with sinus tract of a length of about 1inches leading to a pocket on top of the mesh starting at the middle of the incision. Anesthesia: mac [monitored anesthesia care] plus 5. 5 cc of 0. 05% marcaine. Complications: none. Blood loss: none. Drains: jp into the bottom of this pocket. Procedure: ¿with the patient under adequate sedation and local anesthetic, prepped and draped in the usual sterile fashion, a transverse incision was made and the sinus excised. Then the end of a jp drain was placed at the bottom of this sinus tract and on top an on-q system filled with quarter-strength betadine in saline solution was used to drip diluted betadine in the area. The excised area was then closed with 2-0 vicryl and then 4-0 vicryl subcuticular for the skin. Steri-strips were applied and the dressing was placed. An abdominal binder was secured on top. The patient tolerated the procedure well and left the operating room on good condition. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: infected incisional hernia repair. ¿he is growing the same bacterium staph, coagulase negative staph, that he grew three years ago and by looking at the cultures, it is sensitive to doxycycline and vancomycin only, so it is probably mrsa. He got better with the doxycycline for a little while, but now he needs to be admitted. That wound needs to be opened and packed with betadine soaked gauze and he needs i. V. Vancomycin. He is being admitted. ¿ on (b)(6) 2007: (b)(6) hospital. Inpatient admission. On (b)(6) 2007: (b)(6), md. History and physical. (b)(6) white male with infected graft from abdominal hernia. Past medical history: incisional hernia. Physical exam: abdominal cellulitis. Impression: cellulitis, abdomen. Plan: admit, iv antibiotics. On (b)(6) 2007: (b)(6), md. Discharge summary. Admission diagnosis: cellulitis abdominal mesh infection. Discharge diagnosis: resolving cellulitis mesh infection. Hospital course: ¿the patient was admitted with a deep intense cellulitis over the area of his mesh, where the incisional hernia was repaired. The drain was discharging pus. Because he had grown mrsa in the past, he was placed on vancomycin. He had 4 doses of vancomycin, and when the mic [microscopic] results came from his cultures that were taken on admission, it was a simple staph coagulase negative, sensitive to ancef, so we switched to ancef. Slowly, his cellulitis resolved. It's still there but it's at day 5 of his antibiotic therapy so we're switching to oral antibiotics and we'll discharge him home today. I will see him in the office monday. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: recheck infection. ¿(b)(6) returns after 10 days of i. V. Antibiotics plus oral antibiotics for a rip roaring infection around the area where his fistula was. It was difficult to control. It is healing now. He has finished his course of antibiotics but there is still an opening in the area where the original opening was though smaller. It is healing, so i will see if it persists. I may have to excise that whole thing and pack it open with betadine. I will see him again in one week. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post infected incisional hernia of the mesh. ¿i have begun to do betadine soak wet-to-dry gauzes in the area. I will do it every day and hopefully we will eradicate the chronic infection he has in the very top of his mesh and save it. I will see him tomorrow. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: infected abdominal graft. ¿i changed the pack and replaced it once again with betadine soaked iodoform gauze and i will do so until there is no residual cavity and the original incision is completely closed. It may take a while. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: infected mesh, abdomen. ¿patient is here for his daily dressing changes. The cavity is shrinking. We will see if it goes away completely and the incision closes. I will see him again tomorrow. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: incisional hernia. ¿he clearly has developed an allergy to betadine so i am putting plain gauze in the incision and he has a pretty nice granulation tissue now and i am hoping that this will eventually close this opening permanently. I will see him again tomorrow. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: infected abdominal graft. ¿i took him off the betadine and i packed the incision with plain gauze and the wound is much less soupy and the redness around the area is going away, so he is allergic to betadine. I took a culture of the wound and if the culture comes up negative, then i will once again attempt to close that and i will do that on monday. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post incisional hernia repair. ¿his wound culture has finally turned negative. So i approximated the small opening under sterile conditions with a couple of 4-0 vicryl subcuticulars and then put two mini retention sutures on the skin longitudinally in the forearm of 2-0 nylons. If there was gray granulation tissue and bleeding and there is was [sic] evidence of purulence, if there is no infection and no vascular compromise, hopefully, his incision will stay close. I will see him again on thursday. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post repair of incisional hernia. ¿the good news is that after i closed that small opening, he did not get infected. Time will tell in the next ten days if it will close by itself. I will see him again on monday and on thursday. ¿ (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post incisional hernia repair and secondary closure of skin opening midline. ¿there is no more leakage and i cannot see an opening any more. I will keep the incision covered with a bandaid so it can breathe, so there is no moisture collecting in there. But, there is granulation tissue where the hole was and i cannot see any opening and i cannot see any mesh protruding through any opening. So, maybe, just maybe this may be the beginning of the end of this year long ordeal. ¿ on (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: infectious complications from incisional hernia. ¿there is still an opening there through which i can see the mesh. So since it is clean and there is no infection, we are going to have to let it just granulate in and avoid infection at all costs. Otherwise, there is no way this thing is going to ever close and then we will need a flap, meaning moving the edge of the incision and make a z-incision which is really what i like to do. One more incision is not what i am envisioning for this patient. I will see him again on the 24th. On (b)(6) 2007: office not indicated. (b)(6), md. Office visit. Diagnosis: status post repair of incisional hernia open wound. ¿he has quite a bit of irritation from moisture and i took a culture and if it is sterile then on (b)(6) 2007, i will take him to the or and reexcise the skin incision and close it. I will see him again on thursday (b)(6) 2007 to do a pre-op. ¿ on (b)(6) 2007: (b)(6) hospital. Provider not listed. Bacteriology. Abdominal surgical site. ¿no growth. ¿ on (b)(6) 2008: office not indicated. (b)(6), md. Office visit. Diagnosis: not [sic] healing incision. ¿he will have a reexcision of his incision with coverage of the mesh tomorrow. I am planning to put some retention sutures and have him use his abdominal binder. He is preop for tomorrow. ¿ on (b)(6) 2008: (b)(6) hospital. (b)(6), md. History and physical. ¿(b)(6) white male with non-healing abdominal incision period now cultures are sterile and will cover showing mesh. ¿ ¿exam: abdomen non-healing wound, nontender. Impression: non-healing wound over graft, now sterile. Plan: wound revision. ¿ on (b)(6) 2008: (b)(6) hospital [same day surgery]. (b)(6), md. Operative report. Scar revision. Removal of hypertrophic scar and primary closure of abdominal incision, 4 inches. Preoperative and postoperative diagnosis: non-healing wound, abdomen. Anesthesia: mac plus 12 cc of 0. 05% marcaine without epinephrine. Estimated blood loss: none. Complications: none. Procedure: ¿with the patient under adequate sedation and local anesthetic, prepped and draped in the usual sterile fashion, the entire scar with the exception of the first centimeter was excised and then the fat layer was approximated with 0 vicryl intermittent subcutaneous sutures and the skin was closed with 4-0 vicryl intermittent subcuticular sutures. Dressing was applied. At the end of the procedure, in no was [sic] the priorly exposed mesh that cultured negative lying underneath the skin. The patient tolerated the procedure well and left the operating room in good condition. ¿ on (b)(6) 2008: office not indicated. (b)(6), md. Office visit. Diagnosis: status post removal of scar and non-healing wound, abdomen. ¿his incision looks beautiful. It is closed and is staying together. Hopefully, this will work well for him and we will terminate our biweekly meetings. ¿ implant #2, explant #1 preoperative complaints: on (b)(6) 2008: (b)(6) hospital. [provider not listed]. Emergency department. ¿(b)(6) patient of dr. (b)(6) and dr. (b)(6) who came to the er on the afternoon of on (b)(6) 2008 complaining of a one-day history of vomiting and intense of periumbilical pain that he attributes to umbilical and abdominal wall hernia. He had gore-tex mesh placed by dr. (b)(6) in 2007 that was complicated by post-op skin infections, but overall he feels like he healed well from that event. He has been vomiting every hour or two throughout the afternoon. The vomiting is nonbilious and nonfeculent. He had one loose stool this morning, but says that he has not been passing gas or had any further bowel movements. He does not feel bloated or distended. He thinks the pain is worse after eating fatty food. Review of systems is otherwise unremarkable. He does describe gradually increasing periumbilical pain over the last couple of months and recently saw dr. (b)(6) in mid- october and at that time it was decided that he would wear his abdominal binder. He had also recently completed a course of the releana diet and lost approximately 30 pounds. He has an approximately 3 cm defect to the right of the umbilicus where a reducible hernia is palpable with palpable peristalsis and audible bowel sounds. Bowel sounds are high pitched. He has two smaller defects around the umbilicus just above and to the left. All seem reducible, but come out spontaneously with valsalva or coughing. Abdomen otherwise is unremarkable. Three-view abdominal series shows a few dilated loops of small bowel with air fluid levels and scarcity of air in the left colon and rectum. ¿ on (b)(6) 2008: (b)(6) hospital. (b)(6), md. Radiology. Abdomen 3 view. Indication: ¿abdominal pain. ¿ findings: ¿there are multiple loops of dilated small bowel with air fluid levels and there is a small amount of gas scattered through nondistended colon. The gas pattern is consistent with an early or partial mechanical small bowel obstruction. Small bowel ileus cannot be excluded. The study is otherwise unremarkable. ¿ impression: ¿probable early or partial mechanical small bowel obstruction. ¿ implant #2, explant #1 procedure: lysis of adhesions, repair of incisional hernia. Release of obstruction. [implant: gore® dualmesh® biomaterial, 1dlmc04/05946436, 15cm x 19cm x 1mm thick, oval]. Implant #2, explant #1 date: (b)(6), 2008 [hospitalization (b)(6), 2008]. On (b)(6) 2008: (b)(6) hospital. (b)(6), md. Operative report. Preoperative diagnosis: small bowel obstruction. Recurrent incisional hernia. Postoperative diagnosis: adhesive small bowel obstruction secondary to small bowel adhesions through the underside of the mesh. Recurrent incisional hernia times two. Anesthesia: general. Estimated blood loss: 200 cc. Complications: none. Wound class: i [clean ]. Findings: ¿there were two areas of the diameter of about 2 cm that showed a sack and a defect in the fascia and there were several small bowel loops adherent to the under belly of the mesh. One of them had disparity in caliber consistent with the patient's symptoms of small bowel obstruction. ¿ procedure: ¿with the patient under adequate general anesthesia, prepped and draped in the usual sterile fashion, the prior incision was reopened and carried down through the subcutaneous tissue until the prior mesh was identified. With extreme difficulty and tediously the mesh was detached from the underlying small bowel adhesions and from the prior attachment to the patient's fascia. Finally after the mesh was removed, the small bowel adhesions could be lysed and then the small bowel was run and no other adhesions were found. The abdomen was irrigated with 2 liters of warm ringer's lactate and then attention was turned to the peritoneal coverage of the edges of the fascia and the fascia itself. The peritoneum was stripped for about 5 cm all around and then the fascia layer was identified in its circumference and a new mesh was laid and attached about 3-4 cm away from the edges with intermittent 0 prolene mattress sutures. Care was taken to see that no defect was left so that the bowel could not infiltrate right through underneath the native fascia and mesh. Bleeders were cauterized or tied with 2-0 vicryl and then an on-q was placed right overlying the mesh. The subcutaneous tissue was approximated with 2-0 vicryl interrupted sutures and the skin was closed with interrupted subcuticular sutures and dermabond. The patient tolerated the procedure well and left the operating room in good condition. ¿ on (b)(6) 2008: (b)(6) hospital. Implant sticker. ¿gore dualmesh® biomaterial¿. Ref catalogue number: 1dlmc04. Lot: batch code: 05946436. W. L. Gore & associates. On (b)(6) 2008: (b)(6) hospital. (b)(6), md. Discharge summary. ¿his postoperative course was unremarkable. He is now on a regular diet and discharged home today and i will see him in the office on thursday. ¿ on (b)(6) 2008: (b)(6) hospital. Illegible signature, rn. Discharge instructions. ¿change dressings twice a day and as needed, apply antibiotic ointment. ¿ relevant medical information: on (b)(6) 2008: office not indicated. (b)(6), md. Office visit. Diagnosis: status post repair of incisional hernia. Lysis of adhesions for small bowel obstruction. ¿his skin is so sensitive. He is very, very allergic to everything and i think now he is allergic to penicillin, iodine and sulfa. But his rash is getting better and his, though beat up, does not look infected. There is no seroma underneath the incision, so there is an improvement at this time. I will see him again thursday to make sure that nothing is going wrong. ¿ on (b)(6) 2008: office not indicated. (b)(6), md. Office visit. Diagnosis: status post small bowel obstruction. Recurrent incisional hernia. ¿he has a seroma on the right side of his incision, but it is not very pronounced at this time. I will wait, it could reabsorb by itself or get bigger. If it gets bigger, then i will suck it out with a syringe. That means that i will see him again in one month. His incision looks good and it is not infected. ¿ on (b)(6) 2009: office not indicated. (b)(6), md. Office visit. Diagnosis: status post repair of incisional hernia. ¿his repair is holding. It has been six weeks since surgery. There is no evidence of infection. There no [sic] evidence of recurrence. He has some redness around his incision, but it is a healing incision. It does not appear infected. ¿ on (b)(6) 2009: office not indicated. (b)(6), md. Office visit. Diagnosis: recurrent incisional hernia. ¿it's been over a year now since mr. (b)(6) had his last operation. He does have recurrent incisional hernia. There are weight factors and physical work factors that are contributing to this. The mesh i placed in last time was the biggest i had at the time and it covered all the way around of the edges of the fascia for over 5 cm. There is no evidence of pain, no nausea. He tolerates the defect pretty well and doesn't have any evidence of obstruction or incarceration. Therefore, it is probably best if we leave it alone until there is a problem. I told him what to look for and he knows, having had a bowel obstruction before, what to look for. Return prn [as needed ]. ¿ on (b)(6) 2010: (b)(6) hospital. Inpatient hospitalization. On (b)(6) 2010: (b)(6) hospital. [provider not listed]. Emergency room. Chief complaint: this (b)(6) white male arrives with chief complaint of right-sided abdominal pain. History of present illness: mr. (b)(4) has had right lower quadrant periumbilical pain that began yesterday afternoon that has been up to 8 over 10 in intensity. The pain is described as sharp in nature. The pain is worse with movement or cough or sitting up or laying down. Nothing seems to alleviate the pain. He has had a "clammy-type" feeling, but no definite fevers or chills. He has had nausea, but no vomiting or diarrhea. He has some left testicular pain when he pushes on his right lower quadrant. He has some left -sided back pain. Exam: ¿he was complaining of pain at 8-9 over 10 in intensity. He had moderate tenderness in the right periumbilical right lower abdomen with ¿ [only page 1 provided ].
 
Event Description
It was reported to gore that the patient underwent open epigastric hernia repair on (b)(6), 2005 and (b)(6), 2008 whereby a gore® dualmesh® biomaterial devices were implanted. The complaint alleges that on (b)(6), 2007, (b)(6), 2008 and (b)(6), 2010, additional procedures occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: adhesions, mesh removal, recurrence, fistula, non-healing wound, pain and suffering. Additional event specific information was not provided.
 
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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
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key13292262
MDR Text Key288179486
Report Number3003910212-2022-01325
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K99218
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/11/2013
Device Model Number1DLMC04
Device Catalogue Number1DLMC04
Was Device Available for Evaluation? No
Date Manufacturer Received05/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/19/2022 Patient Sequence Number: 1
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