GORE DUALMESH® PLUS BIOMATERIAL
Report
- Report Number
- 2017233-2019-00993
- Event Type
- Injury
- Date Received
- October 4, 2019
- Date of Event
- June 25, 2005
- Report Date
- June 2, 2022
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 003
Narratives
ADDED MEDICAL HISTORY. CONCLUSION CODE REMAINS UNCHANGED. 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) 2004: (B)(6) HOSPITAL. BILLING RECORD. SUPPLY-IMPLANTS: DUAL PLUS MESH (B)(6); QUANTITY 1. MERSILENE MESH, QUANTITY 2. THE RECORDS CONFIRM A GORE® DUALMESH® PLUS (B)(6) WAS IMPLANTED DURING THE PROCEDURE. 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® PLUS 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.
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: ON UNKNOWN DATE: [MISSING RECORDS: RECORDS FOR ¿HAS HAD A LAPAROSCOPY¿ WERE NOT PROVIDED.]. ON (B)(6) 2000: (B)(6). OFFICE NOTES. HAS UMBILICAL HERNIA THAT IS SYMPTOMATIC. NOTICED THIS DURING PREGNANCY. HAS HAD A LAPAROSCOPY AND MAY BE RELATED TO THAT. SCHEDULED FOR REPAIR. I EXPLAINED THAT IF THE FASCIAL EDGES DO NOT LOOK HEALTHY, I MAY NEED TO PLACE GORTEX OR MARLEX. SHE IS IN AGREEMENT. ON (B)(6) 2000: [MISSING RECORDS: RECORDS, INCLUDING OPERATIVE REPORT, FOR ¿REPAIR UMBILICAL HERNIA- DR. (B)(6)¿ WERE NOT PROVIDED.]. ON (B)(6) 2000: (B)(6). OFFICE NOTES. FOLLOW UP UMBILICAL HERNIA REPAIR. HAD LITTLE BIT OF DRAINAGE FROM INCISION AND SLOUGHING. STARTED ON DURICEF; DOING BETTER NOW. RETURN AS NEEDED. ON (B)(6) 2000: (B)(6). OFFICE NOTES. FOLLOW UP UMBILICAL HERNIA REPAIR. HAD SOME CELLULITIS AT SITE OF HER INCISION BUT HAS RESOLVED. HAS PAIN LEFT OF UMBILICUS BUT I DO NOT FEEL HERNIA. START WEARING HER BINDER AGAIN AND IF PAIN DOESN¿T RESOLVE IN NEXT FEW DAYS/WEEK, WILL CALL FOR RECHECK. ON (B)(6) 2000: (B)(6). OFFICE NOTES. FOLLOW UP UMBILICAL HERNIA REPAIR. DEVELOPED A RECURRENCE. DID NOT USE MESH ON HER LAST REPAIR. IN LIGHT OF RECURRENCE, SHE WILL NEED MESH. ON (B)(6) 2001: [MISSING RECORDS: RECORDS, INCLUDING THE OPERATIVE REPORT, FOR ¿REPAIR OF RECURRENT UMBILICAL HERNIA WITH MARLEX MESH- DR. GARCIA¿ WERE NOT PROVIDED.]. ON (B)(6) 2001: (B)(6). OFFICE NOTES. STATUS POST REPAIR OF VENTRAL HERNIA, HAD MESH PLACEMENT. NO SIGNS OF RECURRENCE. WEAR BINDER FOR AT LEAST ANOTHER 3 WEEKS, AVOID HEAVY LIFTING/STRAINING AT LEAST FOR A MONTH. RETURN AS NEEDED. ON (B)(6) 2001: (B)(6). OFFICE NOTES. FOLLOW UP REPAIR OF RECURRENT UMBILICAL HERNIA WITH MARLEX MESH. HAS AN AREA IN HER UMBILICAL HERNIA REPAIR SITE THAT I THINK IS MESH. IT IS PALPABLE; NOT SURE THERE IS A RECURRENCE. WE WOULD WATCH THIS. SEE HER BACK IN 6 MONTHS TO SEE IF THERE IS A CHANGE. ON (B)(6) 2003: (B)(6). OFFICE NOTES. REFERRED BY DR. (B)(6) FOR EVALUATION OF UMBILICAL HERNIA. REPAIRED TWICE IN THE PAST BY DR. (B)(6); MOST RECENTLY APPROXIMATELY 2 YEARS AGO. DO NOT APPRECIATE AN UMBILICAL HERNIA AT THIS TIME; DO FEEL THE MESH WITH SOME RESIDUAL TISSUE OVERLYING. DOES HAVE MINIMAL TENDERNESS TO PALPATION OF UMBILICUS. SCHEDULED TO UNDERGO HYSTERECTOMY ON (B)(6) 2004 BY DR. (B)(6). IF AN UMBILICAL HERNIA IS PRESENT, I WILL REPAIR IT AT THAT TIME. ON (B)(6) 2004: [MISSING RECORDS: RECORDS, INCLUDING OPERATIVE REPORT, FOR ¿APPENDECTOMY, EXCISION OF VENTRAL HERNIA SACS, REPAIR OF VENTRAL HERNIA WITH MESH GRAFT¿ WERE NOT PROVIDED.]. PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED GORE DEVICE WERE NOT PROVIDED. ON (B)(6) 2004: (B)(6). OFFICE NOTES. UNDERWENT INCIDENTAL APPENDECTOMY WITH REPAIR OF LARGE VENTRAL HERNIA WITH MESH ON (B)(6) 2004. UNDERWENT TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL OOPHORECTOMY BY DR. (B)(6) PRIOR TO MY PROCEDURE. WOUND IS HEALING NICELY. IN MID PORTION, AROUND THE UMBILICUS, THERE IS SOME MILD SEROUS DRAINAGE. REMOVED STERI-STRIPS AND CLEANED THIS AREA WITH HYDROGEN PEROXIDE; NO PURULENT DRAINAGE NOTED. SEE HER BACK IN THREE WEEKS. ON (B)(6) 2004: (B)(6). OFFICE NOTES. SMALL AMOUNT OF DRAINAGE FROM UMBILICUS; SMALL PUNCTATE LESION IN THE MID AREA. PROBED WITH A Q-TIP SOAKED IN HYDROGEN PEROXIDE. UMBILICUS ALSO CLEANED WITH HYDROGEN PEROXIDE AND BACITRACIN OINTMENT APPLIED. WILL START ON LEVAQUIN, CLEAN AREA WITH HYDROGEN PEROXIDE MORNING AND EVENING, KEEP BACITRACIN/STERILE DRESSINGS ON AT ALL TIMES. SEE BACK IN 2-3 WEEKS. ON (B)(6) 2004: (B)(6). OFFICE NOTES. UMBILICAL AREA NOW CLEAN; VERY MINIMAL DRAINAGE ON DRESSING. COMPLETED 10-DAY COURSE OF LEVAQUIN. SMALL UMBILICAL WOUND INFECTION NOW RESOLVED. CONTINUE HAVING HER CLEAN WITH HYDROGEN PEROXIDE TWICE A DAY, BACITRACIN/STERILE DRESSING EVERY DAY. WILL SEE HER BACK IN 2 WEEKS. ON (B)(6) 2004: (B)(6). OFFICE NOTES. WOUND STILL OPEN APPROXIMATELY 2 MM DOWN THE DEPTH OF THE UMBILICUS. SOME ADIPOSE TISSUE EXPOSED. WOUND IS HEALING NICELY, TAKING SOME TIME TO COMPLETELY CLOSE. CONTINUE DRESSING CHANGES WITH HYDROGEN PEROXIDE AND BACITRACIN 3 TIMES A DAY. SEE HER BACK IN ONE MONTH. ON (B)(6) 2004: (B)(6). OFFICE NOTES. UMBILICAL WOUND COMPLETELY CLOSED NOW. NO EVIDENCE INFECTION/DRAINAGE. WILL SEE HER BACK ON AS NEEDED BASIS. ON (B)(6) 2004: (B)(6). OFFICE NOTES. UMBILICAL PAIN/MILD DRAINAGE. SMALL 3 MM OPENING AT THE BASE OF THE UMBILICUS; MILD SEROUS DRAINAGE NOTED. WILL START LEVAQUIN X 10 DAYS. INSTRUCTED TO CLEAN TWICE A DAY WITH HYDROGEN PEROXIDE AND APPLY BACITRACIN OINTMENT. WILL SEE HER BACK IN TWO WEEKS. ON (B)(6) 2004: (B)(6). [PROVIDER NI]. OFFICE NOTES. DID NOT SHOW FOR APPOINTMENT. ON (B)(6) 2005: [MISSING RECORDS: RECORDS FOR ¿EXPLANT OF MESH¿ WERE NOT PROVIDED.] 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® PLUS 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.
D1, D3, D4: UPDATED DEVICE IDENTIFIER INFORMATION. LOT NUMBER UNKNOWN. H6: CONCLUSION CODE REMAINS UNCHANGED.
D17: APPROPRIATE CODE/TERM NOT AVAILABLE. FOR ¿WITHDRAWN COMPLAINT¿. 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 INSUFFICIENT INFORMATION AND NO FINDINGS AVAILABLE AND WILL BE CLOSED AS WITHDRAWN¿ AND ¿CAUSE NOT ESTABLISHED¿. 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® 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.¿ 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. AFTER MULTIPLE REQUESTS, SPECIFIC LOT NUMBER INFORMATION WAS NOT PROVIDED FOR THIS DEVICE, BUT PRODUCT TYPE HAS BEEN CONFIRMED. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED. SECTION C1: NAME: PLUS ANTIMICROBIAL PRODUCT COATING. MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT NUMBER: NOT PROVIDED. 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.
PRODUCT IDENTIFICATION RECORDS FOR THE ALLEGED GORE DEVICE WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. (B)(6). IT SHOULD BE NOTED THAT ALTHOUGH THE BRAND NAME AND LOT # OF A GORE DEVICE HAS NOT BEEN PROVIDED, THE INSTRUCTIONS FOR USE FOR THE VAST MAJORITY OF GORE¿S EPTFE PATCH PRODUCTS THAT ARE INDICATED FOR THE RECONSTRUCTION OF SOFT TISSUE DEFICIENCIES INCLUDE THE FOLLOWING WARNINGS AMONG OTHERS: ¿POSSIBLE 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 VENTRAL / INCISIONAL HERNIA REPAIR ON (B)(6) 2004 WHEREBY AN "ALLEGED GORE DEVICE" WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2005, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: EXPLANT OF MESH REQUIRING AN ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 952950 | GORE DUALMESH® PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female | Hospitalization| R |