GORE DUALMESH® BIOMATERIAL
Report
- Report Number
- 2017233-2019-01176
- Event Type
- Injury
- Date Received
- November 22, 2019
- Date of Event
- December 17, 2007
- Report Date
- June 20, 2022
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132600991
- PMA / PMN Number
- K992189
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: ON (B)(6) 2005: (B)(6), RN. INTRAOPERATIVE REPORT. IMPLANT TO LEFT ABDOMINAL AREA PER DR. (B)(6). IMPLANT STICKER. GORE® DUALMESH® BIOMATERIAL. REF CATALOGUE NUMBER: 1DLMC06. LOT BATCH CODE: 03498625. W.L. GORE & ASSOCIATES. 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." W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
H6: HEALTH EFFECT IMPACT CODE: F26: NO HEALTH CONSEQUENCES OR IMPACT. H6: MEDICAL DEVICE COMPONENT: G04088: MEMBRANE. THIS CLAIM WAS WITHDRAWN, AND THE ALLEGED PRODUCT COMPLAINT IS NO LONGER BEING PURSUED AT THIS TIME. THE INVESTIGATION HAS BEEN COMPLETED. BASED UPON THE TOTALITY OF THE INFORMATION RECEIVED OVER THE COURSE OF THE INVESTIGATION AND REPORTED BY GORE IN THE PREVIOUSLY SUBMITTED MEDICAL RECORD NARRATIVES THE FOLLOWING CONCLUSIONS HAVE BEEN REACHED. AS PREVIOUSLY REPORTED, ALL PERTINENT MEDICAL RECORDS REQUESTED MAY NOT HAVE BEEN RECEIVED. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. BASED UPON GORE¿S INVESTIGATION THERE IS NO AVAILABLE INFORMATION THAT REASONABLY SUGGESTS THAT A GORE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO DEATH, SERIOUS INJURY OR REPORTABLE MALFUNCTION, AND IS NO LONGER CONSIDERED REPORTABLE. THEREFORE, THIS EVENT IS BEING CODED AS NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, NO HEALTH CONSEQUENCES OR IMPACT AND WILL BE CLOSED AS NO PROBLEM DETECTED AND ¿WITHDRAWN." PREVIOUS PATIENT CODES WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. IT SHOULD BE NOTED THAT THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE INCLUDE WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ MEDICAL RECORDS THAT INDICATE MESH ¿MOVEMENT¿ OR THAT THE DEVICE LED TO A RECURRENCE MAY REFLECT A RECURRENCE AS A FUNCTION OF A PATIENT¿S POOR TISSUE QUALITY LEADING TO FASCIAL DEHISCENCE OR LOSS OF ANCHORAGE OF FIXATION, OR MAY BE RELATED TO THE HERNIA TYPE, INDIVIDUAL PATIENT COMORBIDITIES, AND TECHNICAL AND PROCEDURAL ASPECTS OF THE REPAIR. THESE FACTORS INCLUDE BUT ARE NOT LIMITED TO, FIXATION TYPE, MESH SHAPE/SIZING USED, AND DEFECT CLOSURE DECISIONS. ADDITIONALLY, A NEW, UNRELATED HERNIA CAN OCCUR BUT MAY BE REFERRED TO AS A RECURRENT HERNIA. AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH. THESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MESH MIGRATION, MESH CONTRACTION, PAIN, PARESTHESIA, PERFORATION, REVISION/RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT¿S UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES. THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
A4: ADDED PATIENT WEIGHT. B7: ADDED MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: [MISSING RECORDS: RECORDS PRIOR TO 07/08/2005 WERE NOT PROVIDED.] ON (B)(6) 2005: (B)(6) SYSTEM. [SIGNATURE ILLEGIBLE]. HISTORY & PHYSICAL. CHIEF COMPLAINT: INCISIONAL HERNIA. PLAN OF CARE: LAPAROSCOPIC INCISIONAL HERNIA REPAIR. SURGICAL HISTORY: DESMOIDAL TUMOR REMOVED 1999/TUBAL LIGATION. SOCIAL HISTORY: NO ALCOHOL, NO TOBACCO. WEIGHT 215 LBS. MEDICAL HISTORY: REFLUX, HYPOGLYCEMIA, DEPRESSION. ASA: II. ON (B)(6) 2005: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: SAME. OPERATION: LAPAROSCOPIC REPAIR OF INCISIONAL HERNIA. PROCEDURE: ¿UNDER ADEQUATE GENERAL ENDOTRACHEAL ANESTHESIA, THE PATIENTS ABDOMEN WAS PREPPED AND DRAPED IN A STERILE FASHION. A SMALL INCISION WAS MADE IN THE RIGHT UPPER MID CLAVICULAR SUBCOSTAL AREA THROUGH WHICH A VERESS NEEDLE WAS INSERTED IN THE PATIENTS ABDOMINAL CAVITY. IT WAS CHECKED FOR PROPER PLACEMENT WITH HANGING DROP ASPIRATION AND INSTALLATION OF SALINE, AND LOW FLOW INSUFFLATION OF C02 WAS THEN BEGUN CREATING AN ADEQUATE, PNEUMOPERITONEUM UTILIZING 4 LITERS OF CO2. A 5 MM TROCAR WAS INSERTED THROUGH THIS SITE BY A 5 MM SCOPE AND CAMERA TO REVEAL PROPER PLACEMENT WITHOUT ANY EVIDENCE OF SURROUNDING VISCERA OR VASCULAR INJURY. THEN UNDER DIRECT VISION, AN 11 MM TROCAR WAS INSERTED THROUGH A RIGHT LATERAL MID ABDOMINAL INCISION AND ANOTHER 5 MM TROCAR WAS INSERTED THROUGH A LEFT LOWER LATERAL INCISION. TAKE-DOWN OF A FEW ADHESIONS ABOUT THIS LARGE INCISIONAL HERNIA DEFECT WERE DONE. THE EXTENT OF THE HERNIA DEFECT WAS NOTED INTERNALLY AND THEN MARKED CIRCUMFERENTIALLY. THIS EXTERNAL MARKING WAS MEASURED AND FOUND TO ACCOMMODATE BEST A 24 X 18 CM PIECE OF GORE-TEX MESH. THE FOUR QUADRANTS OF THE MESH AND THE SKIN WERE THEN MARKED. ANCHORING SUTURES OF 2-0 PROLENE WERE THEN PLACED AT THESE MARKED SITES. THE MESH WAS THEN PLACED IN THE ABDOMINAL CAVITY THROUGH SMALL OPENINGS IN THE SKIN. SUTURE PASSER WAS PLACED GRASPING THE FOUR PROLENE ANCHORING SUTURES. THIS EFFECTIVELY PULLED THE MESH UP ON TO THE ABDOMINAL WALL AND THEN UTILIZING A SCREW TACKER, THE MESH WAS TACKED AT ITS PERIPHERY TO THE UNDERLYING FASCIA. TO FACILITATE TACKING ON THE RIGHT SIDE OF THE MESH, TWO 5 MM TROCARS WERE INSERTED IN LEFT MID AND LOWER FLANK INCISIONS. WITH THE MESH IN GOOD POSITION, THE ANCHORING SUTURES WERE THEN TIED. GOOD COVERAGE OF THIS LARGE DEFECT WAS THEN NOTED. NO OTHER DEFECTS WERE NOTED IN THIS AREA. THE TROCARS WERE THEN REMOVED AND THE ABDOMINAL CAVITY WAS ALLOWED TO COLLAPSE. NO INTERNAL BLEEDING WAS NOTED. THE SKIN INCISIONS WERE CLOSED WITH RUNNING INTERRUPTED SUBCUTICULAR 4-0 MONOCRYL AND APPROXIMATELY 20 CC OF 0.05% MARCAINE WITH EPINEPHRINE WERE INSTILLED ABOUT THE PUNCTURE AND INCISION SITES. DRESSINGS WERE APPLIED. THE PROCEDURE WAS TERMINATED. ESTIMATED BLOOD LOSS WAS 20 CC. SPONGE AND NEEDLE COUNTS WERE REPORTED AS CORRECTED. POSTOPERATIVELY SHE WAS STABLE AND TAKEN TO THE RECOVERY ROOM.¿ PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED GORE-TEX MESH WERE NOT PROVIDED. ON (B)(6) 2007: (B)(6) SYSTEM. [SIGNATURE ILLEGIBLE]. HISTORY & PHYSICAL. SURGICAL HISTORY: HERNIA/DESMOIDAL TUMOR EXCISION/TUBAL LIGATION/OVARIAN CYSTECTOMY. WEIGHT 231 LBS., BMI 36.2. ABDOMEN: MIDLINE FASCIAL [ILLEGIBLE] ABOUT 10 X 12 CM. IMPRESSION: RECURRENT INCISIONAL HERNIA. PLAN: OPEN REPAIR. ON (B)(6) 2007: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. OPERATION: OPEN REPAIR OF RECURRENT INCISIONAL HERNIA UTILIZED COMPOSIX MESH. PROCEDURE: ¿UNDER ADEQUATE GENERAL ENDOTRACHEAL ANESTHESIA, THE PATIENT¿S ABDOMEN WAS PREPPED AND DRAPED IN STERILE FASHION. A HORIZONTAL INCISION WAS MADE UTILIZING THE PREVIOUS HORIZONTAL SKIN SCAR. IT WAS CARRIED TO THE RIGHT OF THE SKIN SCAR, AND THEN UTILIZING ELECTROCAUTERY, THE INCISION WAS DEEPENED THROUGH SUBCUTANEOUS TISSUES AND UNDERMINING, CREATING A SUBCUTANEOUS FLAP. UPPER AND LOWER SKIN INCISION WAS DONE TO THE EXTENT OF THE PREVIOUSLY MARKED FASCIAL EDGE. AS THE INCISION WAS DEEPENED, OLD PROLENE MESH WAS ENCOUNTERED, WHICH WAS FAIRLY INCORPORATED WITHIN THE PREVIOUS FASCIAL MARGINS. HOWEVER, TO THE RIGHT SIDE, A RECURRENT DEFECT WAS NOTED, WHICH WAS CAUSING HER MOST OF HER SYMPTOMS. THIS OLD PROLENE MESH WAS REMOVED UTILIZING SHARP DISSECTION BACK TO ANTERIOR RECTUS FASCIA. THERE WAS SOME ADHERENCE FROM POSTERIOR RECTUS FASCIA AND RECTUS MUSCLE ON THE UNDERNEATH SIDE OF THIS MESH, BUT THE MESH WAS TOTALLY REMOVED. THE OLD GORE-TEX MESH, WHICH HAD BEEN PLACED LAPAROSCOPICALLY, WAS THEN ENCOUNTERED. IT WAS ALSO DETACHED ON THE RIGHT LATERAL EDGE AND WAS TOTALLY EXCISED, INCLUDING THE NUMEROUS SCREW TACKS, WITH COMPLETE EXCISION OF NOW BOTH PIECES OF MESH. THE FASCIAL EDGES WERE THEN SOUGHT CIRCUMFERENTIALLY, AND WITH GOOD FASCIAL EDGES OBTAINED, A PIECE OF COMPOSIX MESH MEASURING 15 X 11 CM WAS PLACED WITHIN THE DEFECT, WHICH IT NICELY FIT. THERE WAS NO BLEEDING NOTED FROM THE UNDERLYING OMENTUM OR DISSECTION AREAS. WITH A CORRECT PERITONEAL SPONGE COUNT, THE PROLENE PORTION OF THE MESH WAS SUTURED TO THE SURROUNDING FASCIAL MARGINS WITH RUNNING 0 PROLENE SUTURE. THE COMPOSIX GORE-TEX PORTION OF THE MESH UNDERLAY THE FASCIAL EDGES FOR AT LEAST 2 TO 3 CM. WITH THE MESH NOW FIRMLY IN PLACE, IRRIGATION WAS INSTILLED. NO ACTIVE BLEEDING WAS NOTED IN THE AREA. THE SUPERFICIAL SUBCUTANEOUS TISSUES WERE THEN CLOSED WITH RUNNING 3-0 VICRYL. THE SKIN WAS CLOSED USING SUBCUTICULAR 4-0 VICRYL. DRESSINGS WERE APPLIED. THE PROCEDURE WAS TERMINATED. ESTIMATED BLOOD LOSS: APPROXIMATELY 50 CC. SPONGE AND NEEDLE COUNT REPORTED CORRECT. POSTOPERATIVE CONDITION OF THE PATIENT REMAINED STABLE. SHE WAS TAKEN TO THE RECOVERY ROOM.¿ ON (B)(6) 2007: (B)(6) SYSTEM. INTRAOPERATIVE RECORD. WOUND CLASSIFICATION: 1. IMPLANT RECORD. COMPOSIX MESH. ON (B)(6) 2007: (B)(6), MD. PATHOLOGY REPORT. SPECIMEN#: 07: SU55441. PREOP/POSTOP DIAGNOSIS/CLINICAL HISTORY: INCISIONAL HERNIA. FINAL DIAGNOSIS: SOFT TISSUE, ENMESH, INCISIONAL HERNIORRHAPHY: FIBROADIPOSE TISSUE AND SYNTHETIC MESH. MICROSCOPIC DESCRIPTION: MICROSCOPIC EXAMINATION SUPPORTS THE DIAGNOSIS. GROSS DESCRIPTION: SPECIMEN IS RECEIVED IN FORMALIN, LABELED WITH THE PATIENT¿S NAME, DESIGNATED AS ¿MESH¿ AND CONSISTS OF SYNTHETIC MESH WITH ATTACHED METALLIC RINGLETS WEIGHING 152 GMS, TWO PIECES, MEASURING 18 X 14 X 1.3 CM AND 14 X 10.5 X 0.7 CM. ALSO IN THE SPECIMEN CONTAINER ARE FAT AND FIBROUS TISSUE WEIGHING 32 GMS, MEASURING 7.5 X 6 X 2 CM, REPRESENTATIVELY SUBMITTED IN 1 CASSETTE. 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 INSTRUCTIONS FOR GORE® DUALMESH® BIOMATERIAL USE INCLUDES WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
(B)(6). 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.
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2005 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2007, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENT HERNIA; MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1160123 | GORE DUALMESH® BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMC06 | 03498625 | 00733132600991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Hospitalization| R |