• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 12/04/2002
Event Type  Injury  
Event Description
It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2001 whereby a gore® dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2002 and (b)(6) 2005, additional procedures occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: small bowel obstruction, mesh contraction, scarring, surgery to remove mesh, mesh separation, dense adhesions, adhesions to bowel, partial mesh explain, and severe and chronic pain/discomfort. Additional event specific information was not provided.
 
Manufacturer Narrative
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) 2000: (b)(6) hospital. (b)(6), md. History and physical. Admitted: (b)(6), 2000. Chief complaint: right inguinal hernia. Present illness: ¿this (b)(6)-year-old white male has undergone a colon resection by me for colonic polyposis and diverticulosis and diverticulitis back on (b)(6) of 2000. At that time i could not palpate any inguinal hernias. However, in the postoperative period he came to see me having problems with pain in the right lower quadrant, periumbilical. Area, and he has been found to have a right inguinal hernia which is now felt to be symptomatic. For this reason he is now admitted for repair of this right inguinal hernia. ¿ past medical history: hypertension positive. Past surgical history: appendectomy and colon resection on (b)(6) 2000. Review of systems: he does have some dyspnea upon exertion. For this reason an ekg was done on this patient which showed bradycardia, but was otherwise normal. He is now admitted today for a right inguinal hernia. Physical examination: general appearance: (b)(6)-year-old white male. The abdomen is soft, nondistended. There is a right lower quadrant right inguinal hernia which is reducible. I cannot palpate a hernia on the left in the left inguinal area or the umbilical area. There is a midline incision which is well healed without evidence of herniation. Impression: 1) right inguinal hernia. 2) colonic polyposis. 3) colonic diverticulosis and status post colon resection. 4) essential hypertension. 5) sinus bradycardia. On (b)(6) 2000: (b)(6) hospital. (b)(6), md. Operative record. Pre -operative diagnosis: right inguinal hernia. Post-operative diagnosis: right inguinal hernia, indirect and spermatic cord lipomas. Operation: right inguinal herniorrhaphy and excision of spermatic cord. Surgeon: dr. (b)(6). Anesthesia: general - mr. (b)(6). ¿ procedure: ¿after the satisfactory application of general anesthesia and the patient being given one gram of mefoxin intravenously. His abdomen and right inguinal area and scrotum and genitalia were prepped and draped in a sterile manner. An incision was then made 2 cm above and parallel to the inguinal ligament. The dissection was then carried down through the subcutaneous tissue ligating the venous tributaries as they were encountered going up onto the anterior abdominal wall. The dissection was then carried down to the external oblique aponeurosis. This was then incised along the same line as the original skin incision thereby opening up the inguinal canal. Upon opening the inguinal canal we round the ileoinguinal nerve and then retracted this laterally out of harm's way. Next we then bluntly dissected the spermatic cord structures up out of the inguinal canal. We then examined the inguinal canal. We first examined the posterior inguinal canal medial to the epigastric vessels looking for a direct inguinal hernia and none was found. Next we then explored the spermatic cord structures as they exited through the internal inguinal ring lateral to the epigastric vessels and found the indirect inguinal hernia sac. We then pulled this upward and then tied this along its narrow neck and then resected the sac distal to this and then we allowed the ligated sac to retract back into the peritoneal cavity. After this was done we also spent some time removing two spermatic cord lipomas making sure to stay away from the pampiniform plexus or the blood supply to the testicles and the vas deferens. After this was done we then checked the area for evidence of hemostasis, it was found to be present. We then noticed that there was a bulge and we could not really tell whether this was simply an accumulation of fat or an actual hernia sac which was noted to be interior to the inguinal ligament and could possibly be a femoral hernia. For this reason we then resected this tissue which appeared to be fat off of the femoral triangle and out of the way of the femoral blood vessels. We then at that point also felt beck up in the inguinal canal looking for a defect of a possible femoral hernia. We could find none. It should be noted that we dissected out this femoral area and could easily see the femoral vein, the femoral artery, the empty space and the lvmphatics in the nerves. No femoral hernia was found. We then replaced the spermatic cord structures and the ileoinguinal nerve back into the inguinal canal and then we reapproximated the external oblique aponeurosis over the top of this using multiple interrupted sutures of 2. 0 vicryl. The subcutaneous tissue was lavaged. Adequate hemostasis was made sure of. The subcutaneous tissue was then reapproximated using a continuous suture of 3. 0 plain catgut. The skin was then reapproximated using skin staples. At the end of the procedure gentle traction was placed on the testicle so as to straighten out the spermatic cord structures in the inguinal canal. The final sponge, instrument and needle counts were noted to be correct. Intraoperative duration was forty-five minutes. He was given 800 cc of iv fluids throughout the entire procedure. He had no evidence of any hypotension, dysrhythmias, arterial desaturation or end-tidal co2 volume changes during the entire procedure. He was then allowed to awaken, sterile bandages were applied. It should be noted that approximately 12 cc of 0. 25% marcaine was placed in the subcutaneous tissue for postoperative analgesia. He was then smoothly extubated. His vital signs were stable. He was then gently transferred from the operating table to the recovery room stretcher and sent to the recovery room in stable condition. ¿ on (b)(6) 2000: (b)(6) hospital department of pathology. (b)(6) md. Surgical pathology report. Specimen: hernia sac with spermatic cord lipoma. Final diagnosis: ¿hernia sac with spermatic cord lipoma¿: hernia sac and benign adipose tissue consistent with spermatic cord lipoma. One benign lymph node. Clinical diagnosis and history: right inguinal hernia. Gross description: "hernia sac with spermatic cord lipoma"- consists of a 90 cc aggregate of grossly benign adipose tissue, sampled in cassettes 1 through 3. On (b)(6) 2000: (b)(6) hospital. (b)(6) md. History and physical. Admitted: on (b)(6) 2000. Present illness: ¿this (b)(6)-year-old white male underwent a colon resection by me for a colonic polyposis, diverticulosis and diverticulitis back on (b)(6) of 2000. He has done well. However in the postoperative period ((b)(6) 2000), he was noted to have a hernia at the upper end of his midline incision. This was reducible. He was also recuperating from a right inguinal herniorrhaphy which was found at the time of his initial surgery. He came back to see me on (b)(6) 2000, now having problems with abdominal ventral pain at the upper end of this midline incision with episodes of crampy, severe abdominal pain associated with a knot protruding through this area which is in the midline just above the umbilicus, and when it reduces, the pain goes away. It is felt that we should go ahead and repair this obvious postoperative abdominal ventral hernia in order to prevent incarceration or strangulation. For this reason, the patient is admitted to the hospital. ¿ colonic polyposia, and colonic diverticulosis and diverticulitis. Review of systems: he has had episodes of bradycardia in the past on ekg's. There is no family history of past history of any free bleedings phlebitis, or deep venous thrombosis. Physical examination: abdomen: soft, nondistended. There is an obvious postoperative hernia at the mid portion of his previous midline incision just above the umbilicus. This is a reducible hernia. It is nontender. There is no sign of incarceration or strangulation. He does have a right inguinal incision which is well healed corresponding to his previous right inguinal herniorrhaphy. Bilateral femoral pulses were palpable. No inguinal hernias are palpable bilaterally. Impression: 1) postoperative abdominal ventral hernia, (supraumbilical and midline). 2) colonic diverticulosis. 3) colonic polyposis. 4) essential hypertension. 5) sinus bradycardia. On (b)(6) 2000: (b)(6) hospital. (b)(6) md. Operative record. Pre-operative diagnosis: abdominal ventral hernia. Post-operative diagnosis: multiple abdominal ventral hernias. Operation: multiple abdominal ventral herniorrhaphy. Surgeon: dr. (b)(6). Anesthesia: general, (b)(6). ¿ procedure: ¿after the satisfactory application of general anesthesia and the patient's abdomen being prepped and draped in a sterile manner. He was given 1 gm of mefoxin intravenously. An incision was then made above the umbilicus in the midline where the hernia could be palpated, and then carried down around the left side of the umbilicus, and then below the umbilicus a short distance. We then carried the incision down through the subcutaneous tissue, down to the actual fascia. We found this hernia sac in the midline above the umbilicus. We then entered into the hernia sac itself, and noted that it communicated with the peritoneal cavity. We then placed a finger down underneath this and swept all adhesions away. Once we swept the adhesions away, we noted that there was an approximately 3 cm defect in the midline fascia above the umbilicus, and then we could actually feel a bridge of fascial tissue below this first hernia and then there was another hernia just underneath the actual umbilical area. We transected the bridge of fascia which was then tacked between these two hernia [sic] and made one large hernia. After this was done, we then resected the hernia sacs themselves. We then freshened up the tissue back to the fascia on either side, we then made sure that the abdominal contents were back into the peritoneal cavity. We then placed the omentum over the top of these. The peritoneum was then closed with a dexon plus continuous suture. We then closed the midline fascia using multiple interrupted sutures of 0 mersilene making sure not to ensnare any of the underlying intraperitoneal contents. After this was done, it was completely closed, and there was no further evidence of any defects. We then placed 1/4 inch penrose drain in the subcutaneous tissue. Adequate hemostasis was made sure of. The subcutaneous tissue was then reapproximated with 3-0 plain catgut, and the skin was then reapproximated with skin staples. The final sponge, instrument and needle counts were noted to be correct, and intraoperative duration was 45 minutes. He was given approximately 750cc of lactated ringer's throughout the entire procedure. He was then allowed to awaken. His vital siqns were stable. Sterile bandages were applied. An abdominal binder was applied. He was then allowed to be gently transferred from the operating table to the recovery room stretcher and sent to the recovery room in stable condition. ¿ on (b)(6) 2000: (b)(6) hospital department of pathology. (b)(6), md. Surgical pathology report. Specimen: hernia sac. Final diagnosis: anterior abdominal wall: ventral hernia sac. Clinical diagnosis and history: abdominal ventral hernia. Gross description: received fixed in a container labeled "abdominal ventral hernia¿ are three portions of adipose tissue and wrinkled fibromembranous tissue. The largest measures 3 x 1 x 2 cm. The smallest measures 2 cm in greatest diameter. Selected sections are submitted in one cassette. Implant preoperative complaints: on (b)(6) 2001: (b)(6) hospital. (b)(6), md. History and physical. Chief complaint: hernia. Present illness: ¿this (b)(6)-year-old white male underwent an exploratory laparotomy and left colon resection on (b)(6) 2000. He has done well. However, in the postoperative period on (b)(6) 2000, he was noted to have a hernia at the upper end of his midline incision. This was freely reducible, and he was taken to the operative theater where this was [sic] hernia was repaired primarily. Postoperatively, he did well. However, he came back to see me on (b)(6) 2001, complaining of pain in his stomach, and he is noted to have a recurrent abdominal ventral hernia emanating from the midline, just above the umbilicus over towards the right side. The midline hernia is reducible, and he is now admitted today for repair of this. ¿ past medical history: hypertension positive. Abdomen: soft, nondistended. There is a recurrent abdominal ventral hernia just at the upper portion of the previous midline incision. This is reducible. It is nontender. There is no sign of incarceration of [sic] strangulation. Impression: 1) recurrent abdominal ventral hernia. 2) colonic diverticulosis and polyposis. 3) sinus bradycardia. 4) essential hypertension. ¿ implant procedure: exploratory laparotomy, take-down multiple hernia defects, abdominal ventral herniorrhaphy with dual mesh placement. [implant: gore® dualmesh® biomaterial, (b)(4), 15cm x 19cm x 1mm thick, oval. ] implant date: on (b)(6) 2001 [hospitalization dates unknown] wound classification: [not provided] on (b)(6) 2001: (b)(6) hospital. (b)(6), md. Operative record. Pre-operative diagnosis: recurrent abdominal ventral hernia. Post-operative diagnosis: recurrent abdominal ventral hernia. Anesthesia: general, mr. (b)(6). Procedure: ¿after the satisfactory application of general anesthesia and the patient's abdomen being prepped and draped in a sterile manner, he was given 1gm of ancef. An incision was then made in the previous hernia incision. This was carried down through the skin and subcutaneous tissue. We then got down to the hernia sac itself. We then circumferentially isolated the hernia sac which was noted to be above the umbilicus. We then entered the peritoneal cavity. We then found that there were several hernias present, and with fascial bridges noted in between these. We had to go ahead and take down the complete previous hernia repair in order to repair all of these. The largest of these was above the midline and emanated over towards the patient¿s right side. There was another one just lateral to the umbilicus which emanated over to the patient's left side. Then, there was a smaller one noted below the umbilicus. All the fascial bridges in between these had to be removed. We then removed the hernia sacs in their entirety. We then freshened the tissue back up, finding the actual fascial defect below. There was noted to be a defect of approximately 8 to 10 cm in width and approximately 12 cm in the craniocaudal position. It was felt that this could not be reduced and closed primarily due to increased tension, and for this reason, we took a dual mesh and placed this with the smooth side down into this defect and then we placed a plastic fish down into the actual peritoneal cavity in order to keep the small bowel contents away from the overlying peritoneum and fascial wall. We then grasped the fascial wall. Then using multiple interrupted sutures of 0 mersilene, we then sewed the dual mesh prosthetic hernia sheet all the way around this, grabbing generous portions of the actual defect and out of the actual fascia, and sewing this completely together. This was done while maintaining upward traction on the anterior abdominal wall so as not ensnare any of the underlying contents. After this was completely sewed all the way around in a circumferential manner, using the prolene, then they were tied in placed, and after the fish [visceral retainer] had been removed, and the initial sponge, instrument and needle counts were noted to be correct. Next, we then placed a jackson-pratt drain over the top of the hernia sac. We irrigated, the entire area with bacitracin irrigation solution. We then closed the subcutaneous tissue with multiple layer closure using 3. 0 plain catgut. The skin was then reapproximated with skin staples. The final sponge, instrument and needle counts were noted to be correct. Intraoperative duration was 1 hour and 38 minutes. He was given 1350 cc of iv fluid throughout the entire procedure. He had no evidence of any hypotension, dysrhythmias, arterial desaturation, or end-tidal co2 volume changes. Blood loss estimated was less than 150 cc. Sterile bandages were applied. An abdominal binder was applied. He was then smooth extubated. His vital signs were stable. He was then allowed to be gently transferred from the operating table to the recovery room stretcher and sent to the recovery room in stable condition. ¿ on (b)(6) 2001: (b)(6) hospital. Implant sticker. ¿gore dualmesh® biomaterial. ¿ ref catalogue number: 1dlmc04. Lot batch code: 00582434. W. L gore and associates. On (b)(6) 2001: (b)(6) hospital department of pathology. (b)(6), md. Surgical pathology reportspecimen: abdominal ventral hernia. Final diagnosis: ¿hernia sac¿: - hernia sac. Clinical diagnosis and history: abdominal ventral hernia. Gross description: ¿hernia sac¿ ¿ consists of a 6 x 5 x 4 cm aggregate of tan tissue, sampled in a single cassette. Partial explant preoperative complaints: on (b)(6) 2002: (b)(6) hospital. (b)(6), md. History and physical. Chief complaint: hernia, left side of abdomen. Present illness: ¿this (b)(6)-year-old white male underwent a previous abdominal ventral herniorrhaphy by me with mesh. This was done on (b)(6) of 2001. He came back to see me on (b)(6) 2002, at which time he stated he was having pain for the past two to three days, just lateral to the incision and extending over to the left side of the abdomen. The incision is at the midline. This pain also went into his left back and his left testicle into the left inguinal area. He was having bowel movements. There is no rectal bleeding. He is having good urine output. He was also felt to have some problems with testicular pain. It was felt that he could have some orchiditis. For this reason at that point, he was started on some doxycycline, and he underwent an mri scan of the lumbosacral area and also a ct scan of the abdomen and pelvis. The ct scan of the abdomen and pelvis revealed a recurrence of an abdominal hernia under the mesh extending out onto the left side from just above the umbilicus and around the umbilical area. The mri scan of the lumbosacral area showed degenerative disc disease at l3-l4, l5-s1, and also disc bulge at l4 and l5. He was feeling better. The pain from his testicle went away. We sent him to dr. (b)(6), orthopedic/back specialist, who stated that he felt like all of his pain was coming from his hernia. He was feeling somewhat better; however he had a stroke on (b)(6) of 2002 with a left hemiplegia, which has completely resolved, and it was felt that we should wait at least five to six months before repairing this hernia due to the increased incidence of strokes with patients who have had previous strokes and who are operated on within an acute stroke. For this reason, we have continued to follow this patient. Again, he was last seen by me on (b)(6) 2002 in the office, at which time he was having the same periods of intermittent abdominal pain, especially upon standing, and he has this recurrent abdominal ventral hernia which is reducible and it extends over to the left side. The patient is adamant about having this fixed, and he understands the increased risk of a recurrent stroke due to his previous stroke, and he wants this fixed as soon as possible. We have waited approximately 5 months and we are going to go ahead and schedule this for today and have this repaired. ¿ abdomen: there is a recurrent abdominal ventral hernia which is extending out from the umbilicus toward the patient's left side. There is no sign of incarceration or strangulation. Impression: 1. Recurrent abdominal ventral hernia. 2. Sinus bradycardia. 3. Essential hypertension. 4. Colonic diverticulosis and polyposis. 5. Status post cerebrovascular accident (cva) with left hemiplegia (resolved) on (b)(6) of 2002. ¿ partial explant procedure: exploratory laparotomy, small bowel enterorrhaphy times three, small bowel enterolysis, resection of previous mesh implant (partial), resection of hernia sac and multiple abdominal ventral herniorrhaphies. Partial explant date: on (b)(6) 2002 [hospitalization dates unknown] on (b)(6) 2002: (b)(6) hospital. (b)(6), md. Operative record. Preoperative diagnosis: small bowel intestinal obstruction secondary to intraperitoneal adhesions and an abdominal ventral recurrent hernia. Post-operative diagnosis: small bowel intestinal obstruction secondary to intraperitoneal adhesions and multiple abdominal ventral hernias, right and left side, in periumbilical area. Anesthesia: general. Procedure: ¿after the satisfactory application of general anesthesia and the patient's abdomen being prepped and draped in a sterile manner, he was given one gram of ancef intravenously. We made a midline incision corresponding to the old previous scar, started above the midline and then went down to the left side of the umbilicus and then down below the umbilicus. We extended the incision upward into the epigastric area so we could enter the peritoneal cavity in a more or less virgin area. We took the incision in the epigastric area and extended it all the way down through the subcutaneous tissue down through the fascia. We found the peritoneum. We grasped this. We retracted it upward and entered the peritoneal cavity. Upon entering the peritoneal cavity we then started very carefully heading downward toward the area of the backside of the mesh which we could feel and also the rather large hernia sac which seemed to be emanating from the left lateral side and extending into the left abdomen. There was also another smaller hernia sac over on the patient's right side. This was also taken down. We extended the incision downward. Upon getting down close to the mesh we found that there were several pieces of small bowel which were densely adherent to the backside of this piece of mesh. We had to carefully take these down. After we took these down, we had to repair the serosa on several of these using multiple interrupted sutures of 3. 0 silk. This was done in the form of a small bowel enterorrhaphy times three. We took these all the way down and took all of the adhesions away from the posterior surface of the anterior abdominal wall and mesh. There were several places where these adhesions obviously were obstructive in nature as noted by a place where there would be a dilated loop of bowel stuck to an adhesion and beyond the adhesions the bowel would be decompressed. These were all taken down and placed bark into the peritoneal cavity. It took some time to do this. We then went into the abdominal cavity and did an enterolysis of adhesions of several other areas where there were adhesive bands looping around areas of the small intestine. After this was done we removed all of the small intestine and intestinal peritoneal contents away from the backside of the mesh implant. We went ahead and then dissected the left lateral side of the mesh implant away from the underlying adherent peritoneum and we found that this had completely separated away from the left lateral wall of the fascia. We dissected this all the way down around on the patient's left side. We went ahead and were able to fix the other smaller defect on the right side by simply reapproximating the fascia to the actual side of the mesh implant. We did not take this down. We went ahead and freshened this up all the way around so that we could get good purchase [sic]. We went ahead and resected this rather large hernia sac which was noted to emanate from the left lateral side where the mesh had come loose from the fascia and extended over into the left portion of the abdomen. We removed this in its entirety, including the sac. Adequate hemostasis was made sure of. After this was done we then took multiple continuous sutures of #1 prolene and reapproximated the edge of the gore-tex mesh back over to the real fascia. This was done using multiple interrupted sutures of 0 prolene. We started inferiorly below the hernia site itself and extended this upward along the left lateral side. After this was done we then felt underneath. There was no evidence of any further herniations. We used a fish to keep the peritoneal contents away from the undersurface of the herniporrhaphy site while we were closing this with the #1 prolene suture. We then had an initial sponge, instrument and needle count which was noted to be correct. We then removed all sponges and instruments from the intraperitoneal cavity. When the count was correct we then closed the fascia up above in the epigastric area using a continuous interlocking suture of #1 prolene. This came all the way back down and was then incorporated in the top of the mesh thereby completely obliterating all defects and leaving the mesh in place. Before we closed this we made sure there was good hemostasis in the peritoneal cavity. We checked the areas where we had done the email bowel enterorrhaphies. They were all intact. There was no evidence of any mucosal tears. We then placed the omentum back over the top of this and closed this. After this we then took a jackson -pratt drain and placed it over in the area where the large hernia sac, emanating over onto the left side had been repaired, and brought this over the top of the gore-tex mesh itself. We then checked the area for evidence of hemostasis. It was found to be present. We then closed the subcutaneous tissue with multiple continuous sutures of 0 dexon plus. We then closed the skin with skin sutures. A quarter inch penrose drain was also placed in the subcutaneous tissue in the midline. At the end of the procedure we then took approximately 40 cc of 0. 25% marcaine and injected this subcutaneously around the skin and the incision to assist this patient for postoperative analgesia. The final sponge, instrument and needle counts were noted to be correct. Intraoperative duration was an hour and 37 minutes, he was given 1000 cc of iv fluids throughout the entire procedure. He was carefully watched for changes in his blood pressure; none were found. He had no evidence of any hypotension, hypertension or cardiac dysrhythmias throughout the entire procedure. His end-tidal co2 volume changes were normal and his oxygen saturation remained at 99%. He tolerated the procedure well. Sterile bandages were then applied, as well as an abdominal binder. He was smoothly extubated. His vital signs were stable. He was then gently transferred from the operating table to the recovery room stretcher and sent to the recovery room in stable condition. ¿ on (b)(6) 2002: (b)(6) hospital department of pathology. (b)(6), m. D. Pathology report. Specimen: ventral hernia sac. Final diagnosis: hernia sac: hernia sac with fibrosis. Clinical diagnosis and history: abdominal ventral hernia. Gross description: received in one container labeled "hernia sack is a sac formed by fibrous membrane backed by fat and measuring 5 cm in greatest diameter and 2. 5 cm in greatest depth. There is some nodularity in one area and this is included in sections submitted in one cassette. Microscopic examination: microscopic examination was performed on the sections submitted. The microscopic findings support the final diagnosis. ¿ explant preoperative complaints: on (b)(6) 2005: (b)(6) medical center. (b)(6), md. (b)(6). , pa-c. History and physical. Chief complaint: abdominal pain. Present illness: ¿this is a (b)(6)-year-old white male, who was admitted to (b)(6) on (b)(6) 2005 with complaints of abdominal pain and vomiting. X-ray and ct were consistent with a small bowel obstruction [sbo]. Ng [nasogastric] tube was placed and a large amount of aspirate was obtained. He had gradual improvement. However, it was felt that he was in need of surgical intervention and he requested to be transferred to archbold. Past medical history: includes a history of hypertension, gerd [gastroesophageal reflux disease], multiple ventral hernias with hernia repairs, sigmoid resection secondary to diverticulitis. Past surgical history: as mentioned, hernia repair and sigmoid resection. He has had an appendectomy as well as a right inguinal hernia repair. Review of systems: positive for high blood pressure, nausea, vomiting, abdominal pain, otherwise noncontributory. Physical examination: abdomen: soft. He does have pain on palpation. No guarding or rebound tenderness is noted. He does have a palpable ventral hernia located under previous surgical scar. Minimal bowel sounds. Extremities: without edema or cyanosis. Impression: small bowel obstruction. Plan: the patient is admitted for exploratory laparotomy with repair of ventral hernia and release of small bowel obstruction. ¿ see attachment for h10/11 continuation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key13182516
MDR Text Key283511845
Report Number2017233-2022-02658
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/10/2005
Device Model Number1DLMC04
Device Catalogue Number1DLMC04
Was Device Available for Evaluation? No
Date Manufacturer Received03/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2000
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/06/2022 Patient Sequence Number: 1
-
-