GORE DUALMESH PLUS BIOMATERIAL
Report
- Report Number
- 2017233-2019-00395
- Event Type
- Injury
- Date Received
- June 12, 2019
- Date of Event
- December 7, 2002
- Report Date
- August 30, 2021
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132601141
- PMA / PMN Number
- K063435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
THE INVESTIGATION HAS BEEN COMPLETED. IN THE ABSENCE OF ADDITIONAL INFORMATION OR MEDICAL RECORDS FROM THE COMPLAINANT, THIS EVENT FILE WILL BE CLOSED WITH THE INFORMATION PROVIDED. PREVIOUS PATIENT CODE (1994-A) WAS REPORTED BASED ON THE ORIGINAL COMPLAINT AND IS NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE¿S INVESTIGATION. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN (B)(6) 2002 THROUGH (B)(6) 2002 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® PLUS BIOMATERIAL DEVICE. PATIENT INFORMATION: MEDICAL HISTORY: CROHN¿S DISEASE; OBESITY; UNKNOWN DATE: 250 LBS. SURGICAL PROCEDURES: UNKNOWN DATE: BOWEL RESECTION: 2002: HYSTERECTOMY. (B)(6) 2002: INCISIONAL HERNIA REPAIR. IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL. (B)(6) 2002: EXCISION OF ¿GORE-TEX¿ GRAFT AND ALL SUTURE MATERIAL. IMPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2002: ¿THIS 42-YEAR-OLD WHITE MALE [SIC] IS WELL KNOWN TO ME HAVING MANY YEARS AGO UNDERGONE A BOWEL RESECTION. SHE RECENTLY UNDERWENT A HYSTERECTOMY. POSTOPERATIVELY SHE HAD SEVERE SUDDEN ONSET OF PAIN. CT SCAN REVEALED THE HERNIA WITH OMENTUM WITHIN IT. AFTER THE APPROPRIATE [SIC] OF APPROXIMATELY SIX TO EIGHT WEEKS, THE PATIENT WAS BROUGHT IN FOR INCISIONAL HERNIA REPAIR.¿ IMPLANT PROCEDURE: INCISIONAL HERNIA REPAIR. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL 1DLMCP07/01120840, 20 CM X 30 CM X 1MM THICK]. IMPLANT DATE: (B)(6) 2002. FINDINGS: ¿THERE WERE MULTIPLE HERNIAS IDENTIFIED THROUGHOUT THE ENTIRE ABDOMINAL INCISION. THERE WAS A LARGE INFERIOR ABDOMINAL HERNIA THAT HAD OMENTUM WITHIN IT.¿ DESCRIPTION OF HERNIA BEING TREATED: ¿THE PREVIOUS INCISION WAS OPENED FROM XIPHOID TO PUBS [SIC], BLEEDING BEING CONTROLLED WITH ELECTROCAUTERY. DISSECTION WAS CARRIED DOWN. THE HERNIA SACS WERE IDENTIFIED AND DISSECTED FREE. THERE WERE TWO LARGE INFERIOR HERNIAS AND MULTIPLE SMALL HERNIAS THROUGHOUT THE INCISION. THE LARGEST HERNIA WAS JUST ABOVE THE PUBS [SIC]. RESECTION WAS CARRIED BACK UNDER THE FAT TO THE FASCIA INTO THE RECTUS MUSCLE TO BE IDENTIFIED BEHIND THE FASCIA. THIS DISSECTION WAS CARRIED CIRCUMFERENTIALLY FROM LATERALLY TO BOTH SIDES AND SUPERIOR INFERIORLY TO GOOD FASCIA. THE MULTIPLE HERNIA SACS WERE THEN REDUCED AND IMBRICATED WITH 2-0 VICRYL USING THE FASCIAL EDGES TO HELP SECURE THIS.¿ IMPLANT SIZE AND FIXATION: ¿A LARGE DUAL MIX [SIC] GORTEX PLUS GRAFT WAS BROUGHT TO THE FIELD AND TAILORED THE FIT IN THE DEFECT. IT WAS THEN SUTURED TO THE DEFECT WITH A RUNNING CV2 GORTEX STITCH RUNNING CIRCUMFERENTIALLY USING TWO SUTURES TO SECURE THE ENTIRE GRAFT. THE WOUND WAS IRRIGATED WITH ANTIBIOTIC SOLUTION BEFORE AND AFTER PLACING THE GRAFT AND PRIOR TO TOUCHING THE GRAFT, ALL GLOVES WERE CHANGED. TWO BLAKE DRAINS WERE THEN PLACED THROUGH SEPARATE STAB WOUNDS ON TOP OF THE GRAFT. THEY WERE SUTURED IN PLACE WITH 3-0 NYLON. THE FAT WAS CLOSED IN TWO LAYERS WITH 2-0 VICRYL, THE SKIN WITH SKIN CLIPS.¿ NO POST-OPERATIVE RECORDS WERE PROVIDED. EXPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2002: ¿THIS 42-YEAR-OLD, WHITE FEMALE IS WELL KNOWN TO ME. SHE HAS HAD SURGERY FOR CROHN¿S DISEASE IN THE PAST AND RECENTLY UNDERWENT A HYSTERECTOMY AND DEVELOPED A HERNIA POST HYSTERECTOMY THAT WAS PAINFUL. THE HERNIA WAS REPAIRED WITH GORE-TEX MESH. SHE DID WELL, HOWEVER STARTED DRAINING A SEROMA, WHICH BECAME INFECTED. DESPITE MULTIPLE COURSES OF ANTIBIOTICS OVER THE LAST TWO MONTHS, THIS HAS NOT HEALED. SHE WAS BROUGHT IN AT THIS TIME WITH SEPSIS. AFTER APPROXIMATELY A WEEK OF ANTIBIOTICS, SHE¿S FINALLY AGREED WITH REMOVAL OF THE MESH.¿ EXPLANT PROCEDURE: EXCISION OF ¿GORE-TEX¿ GRAFT AND ALL SUTURE MATERIAL. EXPLANT DATE: (B)(6) 2002. ¿A MIDLINE INCISION WAS REOPENED THROUGH THE SUBCUTANEOUS TISSUE AND FAT DOWN TO THE GRAFT. THE GRAFT WAS FOUND TO BE INTACT BUT INCORPORATED WITH WHAT APPEARED TO BE PUS. SHE HAS GROWN OUT STAPHYLOCOCCUS, CULTURES WERE TAKEN. THE SUTURE WAS CUT AND THE GRAFT AND THE ENTIRE GORE-TEX SUTURE, WHICH WAS SEWN IN WITH ONE CONTINUOUS SUTURE WAS EXCISED. THE PATIENT WAS THE [SIC] IRRIGATED WITH 3 LITERS OF SALINE, PACKED WITH KERLIX ROLLS SOAKED IN 50% BETADINE AND SALINE. SHE WILL BE PLACED ON A VACUUM SUCTION DEVICE STARTING MONDAY. HER OVERALL PROGNOSIS IS SATISFACTORY.¿ MICROBIOLOGY REPORTS FOR CULTURES COLLECTED DURING THE (B)(6) 2002 PROCEDURE WERE NOT PROVIDED. PATHOLOGY REPORTS FOR SPECIMENS COLLECTED DURING THE (B)(6) 2002 PROCEDURE WERE NOT PROVIDED. CONCLUSIONS: IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE INCLUDE WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: ¿POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.¿ THE INSTRUCTIONS FOR USE FURTHER WARN: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ PROCEDURE AND SPECIFIC PATIENT FACTORS MAY CONTRIBUTE TO OR CAUSE INFECTION, LEADING TO CONTAMINATION, EXPOSURE, LACK OF INCORPORATION AND/OR SEEDING OF DEVICE. PROCEDURE RELATED FACTORS MAY INCLUDE ADHERENCE TO CLINICAL GUIDELINES ON INFECTION RISK MANAGEMENT, CONTAMINATION OF DEVICE PRIOR TO OR DURING IMPLANT, AND POST-OPERATIVE PERSISTENT/SYMPTOMATIC SEROMA AND WOUND MANAGEMENT. PATIENT RISK FACTORS MAY INCLUDE DIABETES, SMOKING, AGE, MALNUTRITION, IMMUNOSUPPRESSIVE THERAPY, POST-OPERATIVE INSTRUCTION NONCOMPLIANCE, AND HYGIENE. AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH. THESE MY 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 AND STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. SECTION C1: NAME: PLUS ANTIMICROBIAL PRODUCT COATING. MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT NUMBER: 01120840. ADDITIONAL MANUFACTURER NARRATIVE: THE PLUS ANTIMICROBIAL PRODUCT COATING CONTAINS SILVER CARBONATE [APPROXIMATELY 800 MICROGRAMS PER CUBIC CENTIMETER OF PRODUCT (G/CM3)], AND CHLORHEXIDINE DIACETATE [APPROXIMATELY 1600 MICROGRAMS PER CUBIC CENTIMETER OF PRODUCT (G/CM3)]. 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.
ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: RECORDS PRIOR TO (B)(6) 2002, INCLUDING RECORDS FOR BOWEL RESECTION AND HYSTERECTOMY, WERE NOT PROVIDED. ON (B)(6) 2002: (B)(6) HOSPITAL. (B)(6), DO. OPERATIVE REPORT. PREOP DIAGNOSIS: PAINFUL INCISIONAL HERNIA STATUS POST HYSTERECTOMY. POSTOP DIAGNOSIS: MULTIPLE INCISIONAL HERNIAS, STATUS POST HYSTERECTOMY AND BOWEL RESECTION. OPERATION: ___ [SIC]. THIS 42-YEAR-OLD WHITE MALE [SIC] IS WELL KNOWN TO ME HAVING MANY YEARS AGO UNDERGONE A BOWEL RESECTION. SHE RECENTLY UNDERWENT A HYSTERECTOMY. POSTOPERATIVELY SHE HAD SEVERE SUDDEN ONSET OF PAIN. CT SCAN REVEALED THE HERNIA WITH OMENTUM WITHIN IT. AFTER THE APPROPRIATE [SIC] OF APPROXIMATELY SIX TO EIGHT WEEKS, THE PATIENT WAS BROUGHT IN FOR INCISIONAL HERNIA REPAIR. FINDINGS AT THE TIME OF SURGERY: THERE WERE MULTIPLE HERNIAS IDENTIFIED THROUGHOUT THE ENTIRE ABDOMINAL INCISION. THERE WAS A LARGE INFERIOR ABDOMINAL HERNIA THAT HAD OMENTUM WITHIN IT. PROCEDURE: ¿UNDER GENERAL ANESTHESIA, THE PATIENT WAS PROPERLY PREPPED AND DRAPED. THE PREVIOUS INCISION WAS OPENED FROM XIPHOID TO PUBS [SIC], BLEEDING BEING CONTROLLED WITH ELECTROCAUTERY. DISSECTION WAS CARRIED DOWN. THE HERNIA SACS WERE IDENTIFIED AND DISSECTED FREE. THERE WERE TWO LARGE INFERIOR HERNIAS AND MULTIPLE SMALL HERNIAS THROUGHOUT THE INCISION. THE LARGEST HERNIA WAS JUST ABOVE THE PUBS [SIC]. RESECTION WAS CARRIED BACK UNDER THE FAT TO THE FASCIA INTO THE RECTUS MUSCLE TO BE IDENTIFIED BEHIND THE FASCIA. THIS DISSECTION WAS CARRIED CIRCUMFERENTIALLY FROM LATERALLY TO BOTH SIDES AND SUPERIOR INFERIORLY TO GOOD FASCIA. THE MULTIPLE HERNIA SACS WERE THEN REDUCED AND IMBRICATED WITH 2-0 VICRYL USING THE FASCIAL EDGES TO HELP SECURE THIS. A LARGE DUAL MIX GORTEX PLUS GRAFT WAS BROUGHT TO THE FIELD AND TAILORED THE FIT IN THE DEFECT. IT WAS THEN SUTURED TO THE DEFECT WITH A RUNNING CV2 GORTEX STITCH RUNNING CIRCUMFERENTIALLY USING TWO SUTURES TO SECURE THE ENTIRE GRAFT. THE WOUND WAS IRRIGATED WITH ANTIBIOTIC SOLUTION BEFORE AND AFTER PLACING THE GRAFT AND PRIOR TO TOUCHING THE GRAFT, ALL GLOVES WERE CHANGED. TWO BLAKE DRAINS WERE THEN PLACED THROUGH SEPARATE STAB WOUNDS ON TOP OF THE GRAFT. THEY WERE SUTURED IN PLACE WITH 3-0 NYLON. THE FAT WAS CLOSED IN TWO LAYERS WITH 2-0 VICRYL, THE SKIN WITH SKIN CLIPS. DRAINS WERE PLACED TO SUCTION. STERILE DRESSINGS WERE APPLIED. THE PATIENT AWOKE AND RETURNED TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.¿ ON (B)(6) 2002: (B)(6) HOSPITAL [ASSIGNED]. IMPLANT STICKERS. DUALMESH CORDUROY ANTIMICROBIAL. ITEM# 1DLMCP07. LOT# 01120840. THE RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP07/01120840) WAS IMPLANTED DURING THE PROCEDURE. [MISSING RECORDS: RECORDS FOR THE SEROMA, SEPSIS, MULTIPLE COURSES OF ANTIBIOTICS WERE NOT PROVIDED]. (B)(6) 2002: (B)(6) HOSPITAL. (B)(6), DO. OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: INFECTED GORE-TEX GRAFT. OPERATION: EXCISION OF GORE-TEX GRAFT AND ALL SUTURE MATERIALS. COMPLICATIONS: NONE. INDICATIONS: THIS 42-YEAR-OLD, WHITE FEMALE IS WELL KNOWN TO ME. SHE HAS HAD SURGERY FOR CROHN¿S DISEASE IN THE PAST AND RECENTLY UNDERWENT A HYSTERECTOMY AND DEVELOPED A HERNIA POST HYSTERECTOMY THAT WAS PAINFUL. THE HERNIA WAS REPAIRED WITH GORE-TEX MESH. SHE DID WELL, HOWEVER STARTED DRAINING A SEROMA, WHICH BECAME INFECTED. DESPITE MULTIPLE COURSES OF ANTIBIOTICS OVER THE LAST TWO MONTHS, THIS HAS NOT HEALED. SHE WAS BROUGHT IN AT THIS TIME WITH SEPSIS. AFTER APPROXIMATELY A WEEK OF ANTIBIOTICS, SHE¿S FINALLY AGREED WITH REMOVAL OF THE MESH. OPERATIVE PROCEDURE: ¿UNDER GENERAL ANESTHETIC, THE PATIENT WAS PROPERLY PREPPED AND DRAPED. A MIDLINE INCISION WAS REOPENED THROUGH THE SUBCUTANEOUS TISSUE AND FAT DOWN TO THE GRAFT. THE GRAFT WAS FOUND TO BE INTACT BUT INCORPORATED WITH WHAT APPEARED TO BE PUS. SHE HAS GROWN OUT STAPHYLOCOCCUS, CULTURES WERE TAKEN. THE SUTURE WAS CUT AND THE GRAFT AND THE ENTIRE GORE-TEX SUTURE, WHICH WAS SEWN IN WITH ONE CONTINUOUS SUTURE WAS EXCISED. THE PATIENT WAS THE IRRIGATED WITH 3 LITERS OF SALINE, PACKED WITH KERLIX ROLLS SOAKED IN 50% BETADINE AND SALINE. SHE WILL BE PLACED ON A VACUUM SUCTION DEVICE STARTING MONDAY. HER OVERALL PROGNOSIS IS SATISFACTORY.¿ [MISSING RECORDS: A CULTURE REPORT DETAILING ANALYSIS OF THE SPECIMENS COLLECTED DURING THE (B)(6) 2002 PROCEDURE WAS NOT PROVIDED]. [MISSING RECORDS: A PATHOLOGY REPORT DETAILING ANALYSIS OF THE DEVICE REMOVED DURING THE (B)(6) 2002 PROCEDURE WAS NOT PROVIDED]. THERE IS NO INFORMATION DETAILING THE ETIOLOGY OF THE INFECTION. A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE IS UNCLEAR FROM THE PROVIDED INFORMATION AT THIS TIME. IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR 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.¿ THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: ¿STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
H6: UPDATED RESULTS CODE. CONCLUSION CODE REMAINS UNCHANGED.
(B)(6). IT SHOULD BE NOTED THAT THE GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR 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.¿ THE GORE® DUALMESH® PLUS 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.¿
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2002 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2002, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH INFECTION, MESH REMOVAL, PAIN, ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 484893 | GORE DUALMESH PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMCP07 | 01120840 | 00733132601141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization| R |