GORE DUALMESH PLUS BIOMATERIAL
Report
- Report Number
- 2017233-2019-00406
- Event Type
- Injury
- Date Received
- June 12, 2019
- Date of Event
- June 21, 2007
- Report Date
- August 27, 2021
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTL
- UDI-DI
- 00733132601110
- PMA / PMN Number
- K063435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
CONCLUSION CODE REMAINS UNCHANGED. 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) 2007, INCLUDING RECORDS FOR CESAREAN SECTIONS, V-BAND GASTROPLASTY AND HERNIA REPAIR (1990) , EXCISION SKIN ABDOMEN, TOTAL HYSTERECTOMY, HERNIA REPAIR; LAPARO [LAPAROSCOPIC] PARTIAL COLECTOMY, WERE NOT PROVIDED. ??/??/09: [MISSING RECORDS: RECORDS FOR THE ¿HERNIA REPAIR, LAPARO [SIC] PARTIAL COLECTOMY¿ WERE NOT PROVIDED.] (B)(6) 2014: (B)(6) CENTER. (B)(6), ARNP. OFFICE NOTES. CC: REFILLS, CHECK-UP. HISTORY PRESENT ILLNESS (HPI): REPORTS SHE IS UNDER A GREAT DEAL OF STRESS DUE TO FAMILY ILLNESS. WANTS TO BE EVALUATED FOR CANCER AND DIABETES. PMH: OBESITY, ANEMIA-IRON DEFICIENT, GERD, COPD, HEPATOSPLENOMEGALY D/T OBESITY, EDEMA. PAST SURGICAL HISTORY (PSH): C-SECTION 1983 AND 1985, HERNIA REPAIR 2009, LAPARO [SIC] PARTIAL COLECTOMY 2009, TOTAL HYSTERECTOMY 03/1997, EXC SKIN ABD 01/1996, V-BAND GASTROPLASTY 03/1991. SOCIAL HX: FORMER SMOKER; 1PPD X 31 YEARS+, ALCOHOL NONE. CURRENT MEDS: ALBUTEROL SULFATE FOR NEBULIZER, SYMBICORT INHALER, VENTOLIN HFA INHALER. ROS: REPORTS WEIGHT GAIN (20 LBS), NONHEALING ABDOMINAL SURGICAL WOUND. EXAM: WT 415 LBS, BMI 73.5. O2SAT 88%. ABDOMEN: BOWEL SOUNDS NORMAL, NO TENDERNESS, GUARDING, MASSES, REBOUND TENDERNESS, SOFT, NON-DISTENDED, NON-HEALING ABDOMINAL WOUND. ASSESSMENT/PLAN: EDEMA; FUROSEMIDE. OBESITY. GERD; OMEPRAZOLE. COPD; VENTOLIN HFA. RETURN TO OFFICE 10/08/14. (B)(6) 2014: (B)(6) CENTER. (B)(6), ARNP. OFFICE NOTES. CC: REFILLS, CHECK-UP, LEFT JOINT PAIN. HPI: PAIN IN HER LEFT HIP RADIATING INTO HER LEFT GROIN. PAIN IS SIMILAR TO PAIN SHE HAD WITH HER RIGHT HIP BEFORE IT WAS REPLACED. HAVING FOUL SMELLING DRAINAGE FROM THE CHRONIC ABDOMINAL WOUND. EXAM: WT 415 LBS. LIMITED AMBULATION- WITH CANE. ABDOMEN: BOWEL SOUNDS NORMAL, SOFT, NON-DISTENDED, NON-HEALING ABDOMINAL WOUND. TENDERNESS AND LIMITED ROM; LEFT HIP. EDEMA, DISCOLORATION LOWER THIRD OF BOTH LEGS. LAB: ALBUMIN 3.7, LOW; GLUCOSE SERUM 111, HIGH. ASSESSMENT/PLAN: HIP PAIN; WILL GET X-RAY OF LEFT HIP, CELLULITIS; VITAMIN B-12 AND KEFLEX 500MG QID X 10 DAYS. RETURN TO OFFICE (B)(6) 2015. 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.¿ A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE IS UNCLEAR FROM THE PROVIDED INFORMATION AT THIS TIME. 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.
B7: ADDED MEDICAL HISTORY. H6: UPDATED RESULTS CODE 2 FOR STERILIZATION EVALUATION. 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) 2013: (B)(6) REGIONAL MEDICAL CENTER. (B)(6) , MD. WOUND CARE PROGRESS NOTE. FOLLOW UP. SURGICAL FULL THICKNESS ULCER OF MID ABDOMEN WITH FOREIGN BODY MESH. SHE USED TRIPLE ANTIBIOTIC OVER THE LEFT SHIN AND RIGHT SHIN AND SHE HAS BEEN AMBULATING WITHOUT PROBLEM AND LEAVE WOUND OPEN FOR THE WOUND OVER THE MID ABDOMEN FROM PREVIOUS SURGICAL ULCER WITH MESH, THE WOUND WAS DRY AND NO TREATMENT OFFERED. SURGICAL HISTORY: HERNIA REPAIR IN MID ABDOMEN IN 2008, NON-HEALING WOUND WITH MESH FOREIGN BODY IN THE CRATER NOW. EXAM: MORBIDLY OBESE, NONTENDER WITH DRY CRATER OF MID ABDOMEN SURGICAL WOUND WITH MESH. NO DRAINAGE. PLAN: SURGICAL FULL THICKNESS ULCER OF ABDOMEN WITH MESH WILL BE LEFT ALONE, NO NEED FOR TREATMENT. ON (B)(6) 2014: (B)(6) REGIONAL MEDICAL CENTER. (B)(6), MD. WOUND CARE PROGRESS NOTE. CHIEF COMPLAINT: RECURRENT INFECTION ON NON-HEALED SURGICAL WOUND. HISTORY OF PRESENT ILLNESS: HAD GASTRIC VERTICAL BANDING IN 1984 WITH SUBSEQUENT HERNIA REPAIRS WITH MESH HAS BEEN HAVING RECURRENT INFECTIONS WITH A DRAINAGE AND ODOR IN A NON-HEALED AREA WHERE THE UMBILICUS WOULD HAVE BEEN. ULCER EVENTUALLY CLOSES BUT, ABOUT 1-1/2 WEEK AGO, PATIENT NOTICED SOME DRAINAGE AND ODOR AND BEGAN TAKING BACTRIM. EXAM: ABDOMEN: MARKEDLY OBESE WITH MULTIPLE HEALED SCARS. THERE IS OPEN CHRONIC ULCERATION WITHIN THE MIDLINE INCISION. SKIN AND WOUNDS: ULCERATED WOUND NUMBER 1. THERE IS SOME MESH WHICH PROTRUDES AT THE PERIPHERY AND AT THE CENTER OF THE CHRONIC ULCER. ASSESSMENT: RECURRENT INFECTION OF A NONHEALING SURGICAL WOUND WITH CHRONIC ULCERATION AND PROTRUSION OF MESH. ON (B)(6) 2014: (B)(6) REGIONAL MEDICAL CENTER. (B)(6), MD. WOUND CARE PROGRESS NOTE. CHIEF COMPLAINT: RECURRENT INFECTION OF A NON-HEALED SURGICAL WOUND. EXAM: SKIN AND WOUNDS: ULCERATED WOUND #1 IS SURGICAL WOUND IN THE MID ABDOMEN, ACTUALLY IS NOT OPEN, BUT ALONG THE EDGES WHERE THERE IS MESH PROTRUDING, PATIENT HAS SOME DRAINAGE. PLAN: SNIPPED AWAY SOME OF THE PROTRUDING MESH. WILL CONTINUE USING TRIPLE ANTIBIOTIC IN THIS AREA. ON (B)(6) 2014: (B)(6) REGIONAL MEDICAL CENTER. (B)(6), MD. WOUND CARE PROGRESS NOTE. CHIEF COMPLAINT: RECURRENT INFECTION OF A NON-HEALED SURGICAL WOUND. EXAM: ABDOMEN: ULCERATED WOUND #1 IN THE MID ABDOMEN SHOWS NOT ACTUAL OPEN AREA. THERE IS NO EXUDATE. NO VISIBLE GRANULATION TISSUE, BUT A THIN LAYER OF HEALED SKIN. ASSESSMENT: RECURRENT INFECTION OF A NONHEALING SURGICAL WOUND WITH CHRONIC ULCERATION AND PROTRUSION OF MESH WHICH, UPON PROBING, WE DO SEE THAT THERE IS STILL SOME NON-EPITHELIALIZED TISSUE DEEP WITHIN THE EDGES OF THE WOUND. PLAN: NO MESH TO BE SNIPPED AWAY; HOWEVER, THERE WAS SOME BUILDUP OF SMEGMA UNDERNEATH THE PERIPHERY WOUND. PATIENT WILL USE ANTIBIOTIC OINTMENT SHOULD SHE NOTICE ANY DRAINAGE IN AREA. ON (B)(6) 2014: (B)(6) REGIONAL MEDICAL CENTER. (B)(6), MD. WOUND CARE PROGRESS NOTE. CHIEF COMPLAINT: RECURRENT INFECTION OF A NON-HEALED SURGICAL WOUND. REVIEW OF SYSTEMS: MULTIPLE MEDICAL PROBLEMS. EXAM: MORBIDLY OBESE. ABDOMEN: ULCERATED WOUND #1 IN THE MID ABDOMEN HAS HEALED. ASSESSMENT: RECURRENT INFECTION OF A NON-HEALING SURGICAL WOUND WITH A CHRONIC ULCERATION WHICH HAS HEALED. 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 HEALTH EFFECT H6: UPDATED INVESTIGATION FINDING H6: UPDATED INVESTIGATION CONCLUSIONS H6: HEALTH EFFECT IMPACT CODE: F26: NO HEALTH CONSEQUENCES OR IMPACT H6: MEDICAL DEVICE COMPONENT: G04088: MEMBRANE PREVIOUS PATIENT CODES (1690, 1930, 1994) WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE PER GORE¿S INVESTIGATION. THE INVESTIGATION HAS BEEN COMPLETED. 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. MEDICAL RECORDS: THE KNOWN MEDICAL RECORDS SPAN (B)(6), 2007 THROUGH (B)(6) 2014 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® PLUS BIOMATERIAL. RECORDS FROM (B)(6), 2007 THROUGH (B)(6) 2010 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: SMOKER (B)(6) 2014: 1 PACK/DAY X 31 YEARS+ OBESITY (B)(6) 2014: 415 LBS.; BMI 73.5 (B)(6) 2018: 295 LBS.; BMI 52.3 (B)(6) 2007: CULTURES POSITIVE FOR METHICILLIN RESISTANT STAPH AUREUS [MRSA] GASTROESOPHAGEAL REFLUX DISEASE [GERD] ASTHMA CHRONIC OBSTRUCTIVE PULMONARY DISEASE SURGICAL PROCEDURES: 1983, 1985: CESAREAN SECTION 1988: GASTRIC BYPASS 1990: ABDOMINOPLASTY, HERNIA REPAIR (B)(6) 1991: V-BAND GASTROPLASTY (B)(6) 1997: TOTAL ABDOMINAL HYSTERECTOMY (B)(6) 2007: REPAIR OF MASSIVE VENTRAL HERNIA, SMALL BOWEL RESECTION. IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL. (B)(6) 2007: DEBRIDEMENT OF ABDOMINAL WOUND AND HERNIA REPAIR. IMPLANT: MARLEX MESH 2008: HERNIA REPAIR IN MID ABDOMEN. 2009: HERNIA REPAIR; LAPAROSCOPIC PARTIAL COLECTOMY. 2010: HERNIA REPAIR. (B)(6) 2011: SUBCUTANEOUS TISSUE DEBRIDEMENT. (B)(6) 2011: DEBRIDEMENT OF ABDOMINAL WOUND WITH PARTIAL EXCISION OF WIRE MESH. EXPLANT, MARLEX MESH. RELEVANT MEDICAL INFORMATION: NO INFORMATION PROVIDED. IMPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2007: ¿PT [PATIENT] C/O [COMPLAINS OF] NO BOWEL MOVEMENT FOR 9 DAYS. ALSO C/O ABDOMINAL PAIN AND VOMITING X 2 WEEKS. PT SUPPOSED TO HAVE HERNIA SURGERY.¿ (B)(6) 2007: CT ABDOMEN/PELVIS: ¿STUDY IS LIMITED DUE TO PATIENT BODY HABITUS. THERE IS A VERY LARGE VENTRAL HERNIA IN THE MIDLINE AND SMALLER INFRAUMBILICAL HERNIA LEFT PARAMEDIAN. MULTIPLE LOOPS OF BOWEL ARE CONTAINED WITHIN THE HERNIA SACS. THE LOWERMOST PORTION OF THE HERNIA SAC WAS NOT INCLUDED ON THIS SCAN. THERE IS MODERATE SMALL BOWEL DILATATION. IT APPEARS THAT THE TRANSVERSE COLON EXTENDS INTO THE HERNIA SAC AND THE DISTAL END OF COLON WITHIN AND EXITING THE HERNIA SAC IS COLLAPSED. TRANSITION ZONE IS LIKELY CONTAINED WITHIN THE HERNIA. THERE IS NO DEFINITE INFLAMMATION ON LIMITED STUDY WITHOUT IV CONTRAST. SURGICAL CLIPS ARE NOTED IN THE UPPER ABDOMEN. THERE IS NO FREE AIR OR FREE FLUID IN THE ABDOMEN. THERE IS A 2.4 CM MASS IN THE RIGHT ADRENAL GLAND. MULTIPLE DIVERTICULA ARE NOTED IN THE SIGMOID COLON.¿ (B)(6) 2007: ¿MASSIVE VENTRAL HERNIA, HISTORY OF MORBID OBESITY, NAUSEA AND VOMITING AND BOWEL OBSTRUCTION. URGENT SURGERY RECOMMENDED.¿ IMPLANT PROCEDURE: REPAIR OF MASSIVE VENTRAL HERNIA, SMALL BOWEL RESECTION. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP04/04473908, 15 CM X 19 CM X 1MM, OVAL] IMPLANT DATE: (B)(6) 2007 DESCRIPTION OF HERNIA BEING TREATED: ¿ABDOMEN WAS EXPLORED, MIDLINE INCISION REOPENING THE OLD WOUND. THE PATIENT HAD A HUGE VENTRAL HERNIA WHICH WAS BASICALLY IN THREE PARTS GOING TO THE LEFT LOWER, RIGHT LOWER AND SUPERIOR. ALL SACS WERE DISSECTED FREE FROM THE SUBCUTANEOUS TISSUE. THE FASCIAL DEFECT WAS JOINED MAKING ONE SINGLE DEFECT. PORTIONS OF THE SAC WERE RETAINED FOR LATER CLOSURE. THE SMALL BOWEL WAS THEN FREED UP. THERE WERE NUMEROUS ADHESIONS. SMALL BOWEL OBSTRUCTION POINT WAS SEEN WITH A CLEAR TRANSITION ZONE WHICH WAS LYSED. SEVERAL AREAS OF MESENTERY WERE COMPROMISED IN THE BOWEL, PARTICULARLY IN THE MID ILEUM WHICH WERE SEVERELY COMPROMISED ENOUGH TO REQUIRE RESECTION. A FAIRLY GENEROUS RESECTION WAS DONE OF APPROXIMATELY 100 CM OF SMALL BOWEL AND MID ILEUM. PRIMARY ANASTOMOSIS ACHIEVED WITH TWO FIRINGS OF THE GIA STAPLER CLOSING THE MESENTERY WITH SILK. GREAT PAINS WERE TAKEN TO DECOMPRESS THE BOWEL AND TO AVOID SPILLAGE OF CONTENTS. THE DRAPES WERE CHANGED, BOWEL REPLACED IN THE ABDOMEN.¿ IMPLANT SIZE AND FIXATION: ¿A MESH CLOSURE WAS DONE WITH DUALMESH, 15 CM X 9 CM PIECE WAS USED AND SEWN IN PLACE CIRCUMFERENTIALLY WITH A FEW SUTURES. THE OMENTUM HERNIA SAC WAS THEN PLACED ACROSS THE MESH CLOSURE FOR PROTECTION. THE SKIN AND SUBCU [SUBCUTANEOUS] WERE CLOSED OVER THIS SKIN CLOSED WITH STAPLES. SUCTION DRAINS WERE ALSO PLACED.¿ POST-OPERATIVE PERIOD: [5 DAYS] (B)(6) 2007: DISCHARGE SUMMARY: ¿S/P [STATUS/POST] GASTRIC BYPASS SURGERY WITH A CHRONIC VENTRAL NOW INCARCERATED, TRANSFERRED HERE WITH C/O NAUSEA AND VOMITING FOR APPROXIMATELY WEEK AND A HALF. PREVIOUSLY TAKEN TO OPERATING ROOM, HOWEVER, SURGERY CANCELED DUE TO HYPOTENSION. EXAM: ABDOMEN; LARGE COMPLEX VENTRAL HERNIA, VERY TENDER, EXTENDING INTO THE ABDOMINAL PANNUS. CT SCAN SHOWED LARGE VENTRAL HERNIA WITH LARGE AMOUNTS OF BOWEL LOSS OF DOMAIN IN THE SUBCUTANEOUS BOWEL. HOSPITAL COURSE: WAS HYDRATED, TAKEN IMMEDIATELY TO THE OPERATING ROOM, REPAIR OF VENTRAL HERNIA DONE. HAD AN INCARCERATED STRANGULATED ISCHEMIC BOWEL WITHIN THE HERNIA SAC, WHICH WAS A MULTICOMPONENT COMPLEX HERNIA. SAC WAS RESECTED AND DRAIN WAS PLACED AND MESH REPAIR DONE. POSTOP, DID VERY WELL WITHOUT COMPLICATIONS. WAS KEPT ON ANTIBIOTICS THROUGHOUT STAY AND WILL BE DISCHARGED ON CIPRO.¿ EXPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2007: ¿ADMITTED IN MAY FOR SEVERE ABDOMINAL PAIN, BOWEL OBSTRUCTION, AND UNDERWENT URGENT HERNIA REPAIR WITH INCARCERATED BOWEL. DEVELOPED RECURRENT ABDOMINAL PAIN WITH REDNESS ON ABDOMINAL WALL. WAS SWITCHED FROM CIPRO TO KEFLEX AND APPROXIMATELY THAT SAME DAY HER ABDOMEN ¿BUSTED OPEN¿ AND STARTED TO DRAIN PURULENT-APPEARING FLUID. THAT HAPPENED APPROXIMATELY ONE WEEK AGO. EXAM: ABDOMEN; OBESE, SOFT, BOWEL SOUNDS POSITIVE. MIDLINE [SIC] SURGICAL SITE WITH AN OPEN WOUND THAT GENERALLY APPEARS BLOODY. IT DOES SEEM DEEP, ALTHOUGH I AM UNABLE TO VISUALIZE MESH. NO CREPITANS [SIC] OR BULLAE APPRECIATED. PANNUS IS VAGUELY RED AND INDURATED WITH LIGHT SCALE. NO FLUCTUANCE OR NECROSIS SEEN THERE. IMPRESSION: ABDOMINAL WALL INFECTION WITH ABSCESS, SPONTANEOUS DEHISCENCE/RUPTURE. IN GENERAL, THE WOUND CURRENTLY SEEMS DEEP, ALTHOUGH I CANNOT TELL WHETHER IT EXTENDS TO THE MESH. I AM CERTAINLY CONCERNED THAT IT MIGHT. IF THE MESH IS INVOLVED, THIS COULD BE A CHRONIC/COMPLICATED PROBLEM THAT MAY BE VERY DIFFICULT TO CURE (OR POTENTIALLY EVEN IMPOSSIBLE) WITHOUT MESH REMOVAL. HOWEVER, I AGREE WITH I&D TO HELP FIND THE EXTENT OF INVOLVEMENT AND TO HELP GUIDE FURTHER THERAPEUTIC DECISIONS. SHE NEEDS BROAD SPECTRUM ANTIBIOTICS WITH GRAM POSITIVE/GRAM NEGATIVE COVERAGE AEROBE/ANAEROBE COVERAGE. CURRENTLY THERE IS NO FECULENT DRAINAGE TO SUGGEST A FISTULA.¿ (B)(6) 2007: ¿S/P REPAIR OF INCARCERATED ABDOMINAL HERNIA AND BOWEL RESECTION, NOW HAS INFECTION IN HER WOUND SITE.¿ EXPLANT PROCEDURE: DEBRIDEMENT OF ABDOMINAL WOUND AND HERNIA REPAIR. EXPLANT DATE: (B)(6), 2007 [HOSPITALIZATION (B)(6), 2007] ¿THE PATIENT WAS MORBIDLY OBESE WITH A HUGE ABDOMINAL PANNUS. THIS WAS OPENED VERTICALLY THROUGH THE OLD INCISION. A LARGE AMOUNT OF PUS WAS OBTAINED. THERE WERE NO ENTERIC CONTENTS. EXTENSIVE DEBRIDEMENT WAS DONE OF THE WALLS OF THE ABSCESS CAVITY WITH SOME SKIN RESECTION, PARTICULARLY ON THE RIGHT SIDE. THE FASCIA WAS REMOVED IN ITS ENTIRETY ALONG WITH THE OLD SUTURES. A NEW PIECE OF MARLEX ABOUT 4 X 4 CM WAS INSERTED AND SEWN IN PLACE CIRCUMFERENTIALLY WITH PROLENE SUTURES. AFTER FURTHER DEBRIDEMENT, THE WOUND WAS PACKED WITH BETADINE-SOAKED GAUZE AND COVERED.¿ ¿FINDINGS: GROSSLY INFECTED GORETEX MESH W/ ABSCESS.¿ (B)(6) 2007: MICROBIOLOGY: ¿SOURCE: ABDOMINAL. GRAM STAIN: MODERATE GRAM POSITIVE COCCI IN PAIRS AND GROUPS. ISOLATE: MODERATE GROWTH ***METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS***.¿ (B)(6) 2007: MICROBIOLOGY: ¿SPECIMEN: TISSUE. SOURCE: ABDOMINAL. ISOLATE: MODERATE GROWTH PREVOTELLA BIVIA (BACTEROIDES).¿ (B)(6) 2007: MICROBIOLOGY: ¿SPECIMEN: ABSCESS. SOURCE: ADB [ABDOMINAL] WOUND ADCES [SIC]. GRAM STAIN: RARE WBC¿S [WHITE BLOOD CELLS], MANY RBC¿S [RED BLOOD CELLS], NO ORGANISMS SEEN. ISOLATE: LIGHT GROWTH, ***METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS***¿ (B)(6) 2007: ¿S/P [STATUS POST] DRAINAGE OF ABDOMINAL ABSCESS. ABDOMINAL WOUND 3 X 20 CM X 16 CM X 7.5 CM WITH RED [ILLEGIBLE] WOUND BED WITH SPARSE YELLOW SLOUGH NOTED. NO ODOR. MESH NOTED ON TOP OF WOUND. NOTED MODERATE AMOUNT OF SEROSANGUINOUS DRAINAGE.¿ (B)(6) 2007: DISCHARGE SUMMARY: ¿DIAGNOSIS: WOUND INFECTION. HISTORY: PRESENTED WITH AN INCARCERATED VENTRAL HERNIA COMPLEX SEVERAL WEEKS AGO REPAIRED WITH GORE-TEX MESH, NOW WITH INFECTION OF WOUND. EXAM: ABDOMEN; LARGE OPEN MIDLINE INCISION WITH PURULENT DRAINAGE, SOME REDNESS LOWER ABDOMEN. HOSPITAL COURSE: ADMITTED AND TAKEN TO OPERATING ROOM FOR DEBRIDEMENT. WOUND WAS OPENED UP, SKIN DEBRIDED, SOFT TISSUE DEBRIDED, AND OLD MESH WAS REMOVED AND REPLACED WITH PROLENE MESH, WHICH SHOULD GRANULATE. POSTOP DID WELL, NO COMPLICATIONS, TREATED WITH WOUND VAC, WILL BE DISCHARGE HOME ON THE SAME.¿ (B)(6) 2011: ¿SEEN AT WOUND HEALING CENTER IN THE PAST FOR SURGICAL FULL-THICKNESS ULCER OF RIGHT UPPER HIP AND ABDOMEN. BOTH LESIONS WERE COMPLETELY HEALED WHEN SEEN ON (B)(6) 2010 AND (B)(6) 2010. LOCAL EXAMINATION: WOUND NUMBER 1, ABSCESS FULL-THICKNESS ULCER OF RIGHT ABDOMEN, MEASURES 0.8 X 0.8 X 2.7 WITH UNDERMINING 0.5 CM AT 10 TO 1 OCLOCK [SIC]. NO ESCHAR. MINIMAL SLOUGH. WOUND BASE YELLOW AND PINK COLOR WITH HYPERGRANULATION. GRANULATION TISSUE PINK COLOR WITH HYPERGRANULATION. NO EXPOSED BONE, MUSCLE, OR TENDON. MILD ODOR. MODERATE AMOUNT OF PURULENT YELLOW SEROSANGUINEOUS DRAINAGE. NO EPITHELIUM. PERIWOUND INTEGRITY IS INTACT. TREATMENT AND PLAN: THE PATIENT IS TO HAVE WOUND CULTURE DONE OVER THE RIGHT ABDOMEN ULCER, AND THEN THE WOUND TO BE CLEANED WITH SALINE, APPLIED WITH LIDOCAINE 4 PERCENT GEL.¿ CONCLUSION: 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 GORE® DUALMESH® PLUS BIOMATERIAL INSTRUCTIONS FOR USE ALSO WARNS, ¿AS WITH ANY IMPLANTABLE SURGICAL DEVICE, STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.¿ THE INSTRUCTIONS FOR USE WARNS, ¿WHEN USING THIS DEVICE AS A PERMANENT IMPLANT AND EXPOSURE OCCURS, TREAT TO AVOID CONTAMINATION, OR DEVICE REMOVAL MAY BE NECESSARY.¿ 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. INDIVIDUAL MEDICAL DECISIONS, IF INCONSISTENT AND/OR NON-CONFORMING TO THE DEVICE MANUFACTURER¿S RECOMMENDATIONS, IFU, OR RECOGNIZED BEST PRACTICES, MAY RESULT IN OR CONTRIBUTE TO AN ADVERSE EVENT. 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: 04473908 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.
B7: ADDED MEDICAL HISTORY. H6: UPDATED RESULTS CODE 1 FOR MANUFACTURING EVALUATION. CONCLUSION CODE REMAINS UNCHANGED. H6: ADDED METHOD/RESULTS/CONCLUSIONS CODE 2 FOR STERILIZATION EVALUATION. 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: RECORDS PRIOR TO 2007, INCLUDING RECORDS FOR CESAREAN SECTIONS, GASTRIC BYPASS AND HERNIA REPAIR FROM 1990, AND RECORDS FROM KINGS DAUGHTER FOR HERNIA TREATMENT IN 2007, WERE NOT PROVIDED. (B)(6) 07: PAUL B. HALL REGIONAL MEDICAL CENTER. ADMISSION RECORD. BRIEF ASSESSMENT: PT C/O NO BOWEL MOVEMENT FOR 9 DAYS. ALSO C/O ABDOMINAL PAIN AND VOMITING X 2 WEEKS. PT SUPPOSED TO HAVE HERNIA SURGERY. (B)(6) 07: PAUL B. HALL REGIONAL MEDICAL CENTER. HEMATOLOGY. WBC 12.2 H (4.5-11.0). (B)(6) 07: TEAMHEALTH TELERADIOLOGY. RADIOLOGY ¿ CT ABDOMEN/PELVIS WITHOUT IV CONTRAST. HX: GENERALIZED ABDOMINAL PAIN. FINDINGS: STUDY IS LIMITED DUE TO PATIENT BODY HABITUS. THERE IS A VERY LARGE VENTRAL HERNIA IN THE MIDLINE AND SMALLER INFRAUMBILICAL HERNIA LEFT PARAMEDIAN. MULTIPLE LOOPS OF BOWEL ARE CONTAINED WITHIN THE HERNIA SACS. THE LOWERMOST PORTION OF THE HERNIA SAC WAS NOT INCLUDED ON THIS SCAN. THERE IS MODERATE SMALL BOWEL DILATATION. IT APPEARS THAT THE TRANSVERSE COLON EXTENDS INTO THE HERNIA SAC AND THE DISTAL END OF COLON WITHIN AND EXITING THE HERNIA SAC IS COLLAPSED. TRANSITION ZONE IS LIKELY CONTAINED WITHIN THE HERNIA. THERE IS NO DEFINITE INFLAMMATION ON LIMITED STUDY WITHOUT IV CONTRAST. SURGICAL CLIPS ARE NOTED IN THE UPPER ABDOMEN. THERE IS NO FREE AIR OR FREE FLUID IN THE ABDOMEN. THERE IS A 2.4 CM MASS IN THE RIGHT ADRENAL GLAND. MULTIPLE DIVERTICULA ARE NOTED IN THE SIGMOID COLON. (B)(6) 07: CENTRAL BAPTIST HOSPITAL. ACC REVIEW REPORT. ADDITIONAL INFO: PT WAS AT KINGS DAUGHTER TO HAVE THE HERNIA REPAIRED. WHEN IN SURGERY HAD A REACTION TO THE ANESTHESIA¿BP DROPPED, HR DROPPED, SO SURGERY WAS ABORTED. (B)(6) 07: CENTRAL BAPTIST HOSPITAL. OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: INCARCERATED VENTRAL HERNIA. PROCEDURE(S): REPAIR OF MASSIVE VENTRAL HERNIA, SMALL BOWEL RESECTION. HISTORY: MASSIVE VENTRAL HERNIA, HISTORY OF MORBID OBESITY, NAUSEA AND VOMITING AND BOWEL OBSTRUCTION. URGENT SURGERY RECOMMENDED. DESCRIPTION OF PROCEDURE: ¿WITH THE PATIENT SUPINE, GENERAL ANESTHESIA ADMINISTERED, ABDOMEN PREPPED WITH BETASEPT AND DRAPED. FOLEY CATHETER PLACED. NG TUBE PLACED. ABDOMEN WAS EXPLORED, MIDLINE INCISION REOPENING THE OLD WOUND. THE PATIENT HAD A HUGE VENTRAL HERNIA WHICH WAS BASICALLY IN THREE PARTS GOING TO THE LEFT LOWER, RIGHT LOWER AND SUPERIOR. ALL SACS WERE DISSECTED FREE FROM THE SUBCUTANEOUS TISSUE. THE FASCIAL DEFECT WAS JOINED MAKING ONE SINGLE DEFECT. PORTIONS OF THE SAC WERE RETAINED FOR LATER CLOSURE. THE SMALL BOWEL WAS THEN FREED UP. THERE WERE NUMEROUS ADHESIONS. SMALL BOWEL OBSTRUCTION POINT WAS SEEN WITH A CLEAR TRANSITION ZONE WHICH WAS LYSED. SEVERAL AREAS OF MESENTERY WERE COMPROMISED IN THE BOWEL, PARTICULARLY IN THE MID ILEUM WHICH WERE SEVERELY COMPROMISED ENOUGH TO REQUIRE RESECTION. A FAIRLY GENEROUS RESECTION WAS DONE OF APPROXIMATELY 100 CM OF SMALL BOWEL AND MID ILEUM. PRIMARY ANASTOMOSIS ACHIEVED WITH TWO FIRINGS OF THE GIA STAPLER CLOSING THE MESENTERY WITH SILK. GREAT PAINS WERE TAKEN TO DECOMPRESS THE BOWEL AND TO AVOID SPILLAGE OF CONTENTS. THE DRAPES WERE CHANGED, BOWEL REPLACED IN THE ABDOMEN. A MESH CLOSURE WAS DONE WITH DUALMESH, 15 CM X 9 CM PIECE WAS USED AND SEWN IN PLACE CIRCUMFERENTIALLY WITH A FEW SUTURES. THE OMENTUM HERNIA SAC WAS THEN PLACED ACROSS THE MESH CLOSURE FOR PROTECTION. THE SKIN AND SUBCU WERE CLOSED OVER THIS SKIN CLOSED WITH STAPLES. SUCTION DRAINS WERE ALSO PLACED. THE PATIENT THEN WENT TO THE RECOVERY ROOM IN STABLE CONDITION.¿ (B)(6) 07: CENTRAL BAPTIST HOSPITAL. IMPLANT RECORD. OTHER: VENTRAL WALL. DUAL MESH PLUS. 15 CM X 19 CM X 1 MM. LOT: 04473908. SERIAL/REF: 1DLMCP04. THE RECORDS CONFIRM A GORE® DUALMESH® PLUS BIOMATERIAL (1DLMCP04/04473908) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 07: CENTRAL BAPTIST HOSPITAL. SURGICAL PATHOLOGY. ACCESSION #: S07-5130. CLINICAL DIAGNOSIS AND HISTORY: THE INCARCERATED HERNIA. FINAL DIAGNOSIS: SMALL BOWEL RESECTION: ADHESIONS AND MILD ISCHEMIC CHANGES; NO EVIDENCE OF NEOPLASM. CLINICAL INCARCERATED HERNIA. SPECIMEN(S) RECEIVED: SMALL INTESTINE, RESECTION OTHER THAN FOR TUMOR. GROSS DESCRIPTION: THE SPECIMEN, RECEIVED IN FORMALIN, LABELED BOWEL, CONSISTS OF A 128 CM IN LENGTH SEGMENT OF BOWEL WITH A MODERATE AMOUNT OF ATTACHED TAN/RED, DIFFUSELY HEMORRHAGIC MESENTERIC FAT. THE SEROSA IS TAN/BROWN-TO-RED AND FOCALLY HEMORRHAGIC. THE SPECIMEN IS OPENED TO REVEAL TAN, GLISTENING MUCOSA WITH NORMAL FOLDS. NO MASSES OR AREAS OF PERFORATION ARE APPRECIATED. REPRESENTATIVE SECTIONS ARE SUBMITTED. SUMMARY OF SECTIONS: A-B-RESECTION MARGINS TAKEN FACE; C-G-REPRESENTATIVE SECTIONS OF BOWEL TO INCLUDE CONGESTED HEMORRHAGIC SEROSA; H-REPRESENTATIVE SECTION OF HEMORRHAGIC MESENTERIC FAT. MICROSCOPIC DESCRIPTION: SECTIONS FROM THE MARGINS OF RESECTION SHOW VIABLE SMALL INTESTINAL MUCOSA. ONE OF THE ENDS DOES SHOW SOME SUPERFICIAL ISCHEMIC CHANGE. RANDOM SECTIONS TAKEN ALONG THE LENGTH OF THE BOWEL SHOW ADHESIONS, ENGORGEMENT OF VESSELS AND FOCAL LOSS OF SURFACE VILLI COMPATIBLE WITH ISCHEMIC CHANGE. OTHER AREAS OF HEMORRHAGIC ADHESIONS ARE NOTED. THERE IS NO EVIDENCE OF NEOPLASM. SECTION TAKEN THROUGH THE MESENTERIC ADIPOSE SHOWS A SMALL THROMBUS IN AN ARTERY. (B)(6) 07: CENTRAL BAPTIST HOSPITAL. HEMATOLOGY. WBC 12.25 H (3.5-10.8). (B)(6) 07: CENTRAL BAPTIST HOSPITAL. DISCHARGE SUMMARY. DIAGNOSIS: INCARCERATED STRANGULATED VENTRAL HERNIA. OTHER DIAGNOSES: MORBID OBESITY. HPI: S/P GASTRIC BYPASS SURGERY WITH A CHRONIC VENTRAL NOW INCARCERATED, TRANSFERRED HERE FROM PAINTSVILLE WITH C/O NAUSEA AND VOMITING FOR APPROXIMATELY WEEK AND A HALF. PREVIOUSLY TAKEN TO OPERATING ROOM, HOWEVER, SURGERY CANCELED DUE TO HYPOTENSION. EXAM: ABDOMEN; LARGE COMPLEX VENTRAL HERNIA, VERY TENDER, EXTENDING INTO THE ABDOMINAL PANNUS. LABS: WBC 12,000. CT SCAN SHOWED LARGE VENTRAL HERNIA WITH LARGE AMOUNTS OF BOWEL LOSS OF DOMAIN IN THE SUBCUTANEOUS BOWEL. HOSPITAL COURSE: WAS HYDRATED, TAKEN IMMEDIATELY TO THE OPERATING ROOM, REPAIR OF VENTRAL HERNIA DONE. HAD AN INCARCERATED STRANGULATED ISCHEMIC BOWEL WITHIN THE HERNIA SAC, WHICH WAS A MULTICOMPONENT COMPLEX HERNIA. SAC WAS RESECTED AND DRAIN WAS PLACED AND MESH REPAIR DONE. POSTOP, DID VERY WELL WITHOUT COMPLICATIONS. WAS KEPT ON ANTIBIOTICS THROUGHOUT STAY AND WILL BE DISCHARGED ON CIPRO. (B)(6) 07: CENTRAL BAPTIST HOSPITAL. CONSULTATION. CC: ¿MY STOMACH BUSTED OPEN.¿ HPI: ADMITTED IN MAY FOR SEVERE ABDOMINAL PAIN, BOWEL OBSTRUCTION, AND UNDERWENT URGENT HERNIA REPAIR WITH INCARCERATED BOWEL. DEVELOPED RECURRENT ABDOMINAL PAIN WITH REDNESS ON ABDOMINAL WALL. WAS SWITCHED FROM CIPRO TO KEFLEX AND APPROXIMATELY THAT SAME DAY HER ABDOMEN ¿BUSTED OPEN¿ AND STARTED TO DRAIN PURULENT-APPEARING FLUID. THAT HAPPENED APPROXIMATELY ONE WEEK AGO. EXAM: ABDOMEN; OBESE, SOFT, BOWEL SOUNDS POSITIVE. MIDLINE SURGICAL SITE WITH AN OPEN WOUND THAT GENERALLY APPEARS BLOODY. IT DOES SEEM DEEP, ALTHOUGH I AM UNABLE TO VISUALIZE MESH. NO CREPITANS OR BULLAE APPRECIATED. PANNUS IS VAGUELY RED AND INDURATED WITH LIGHT SCALE. NO FLUCTUANCE OR NECROSIS SEEN THERE. IMPRESSION: ABDOMINAL WALL INFECTION WITH ABSCESS, SPONTANEOUS DEHISCENCE/RUPTURE. IN GENERAL, THE WOUND CURRENTLY SEEMS DEEP, ALTHOUGH I CANNOT TELL WHETHER IT EXTENDS TO THE MESH. I AM CERTAINLY CONCERNED THAT IT MIGHT. IF THE MESH IS INVOLVED, THIS COULD BE A CHRONIC/COMPLICATED PROBLEM THAT MAY BE VERY DIFFICULT TO CURE (OR POTENTIALLY EVEN IMPOSSIBLE) WITHOUT MESH REMOVAL. HOWEVER, I AGREE WITH I&D TO HELP FIND THE EXTENT OF INVOLVEMENT AND TO HELP GUIDE FURTHER THERAPEUTIC DECISIONS. SHE NEEDS BROAD SPECTRUM ANTIBIOTICS WITH GRAM POSITIVE/GRAM NEGATIVE COVERAGE AEROBE/ANAEROBE COVERAGE. CURRENTLY THERE IS NO FECULENT DRAINAGE TO SUGGEST A FISTULA. 06/21/07: CENTRAL BAPTIST HOSPITAL. OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: SEE HISTORY BELOW. PROCEDURE(S): DEBRIDEMENT OF ABDOMINAL WOUND AND HERNIA REPAIR. HISTORY: S/P REPAIR OF INCARCERATED ABDOMINAL HERNIA AND BOWEL RESECTION, NOW HAS INFECTION IN HER WOUND SITE. DESCRIPTION OF PROCEDURE: ¿WITH THE PATIENT SUPINE, GENERAL ANESTHESIA WAS ADMINISTERED. THE PATIENT WAS MORBIDLY OBESE WITH A HUGE ABDOMINAL PANNUS. THIS WAS OPENED VERTICALLY THROUGH THE OLD INCISION. A LARGE AMOUNT OF PUS WAS OBTAINED. THERE WERE NO ENTERIC CONTENTS. EXTENSIVE DEBRIDEMENT WAS DONE OF THE WALLS OF THE ABSCESS CAVITY WITH SOME SKIN RESECTION, PARTICULARLY ON THE RIGHT SIDE. THE FASCIA WAS REMOVED IN ITS ENTIRETY ALONG WITH THE OLD SUTURES. A NEW PIECE OF MARLEX ABOUT 4 X 4 CM WAS INSERTED AND SEWN IN PLACE CIRCUMFERENTIALLY WITH PROLENE SUTURES. AFTER FURTHER DEBRIDEMENT, THE WOUND WAS PACKED WITH BETADINE-SOAKED GAUZE AND COVERED. THE PATIENT THEN WENT TO THE RECOVERY ROOM IN STABLE CONDITION.¿ 06/21/07: CENTRAL BAPTIST HOSPITAL. TATE. OPERATIVE NOTE. FINDINGS: GROSSLY INFECTED GORETEX MESH W/ ABSCESS. BOWEL OK. PROCEDURE: DEBRIDEMENT PROLENE MESH REPAIR PACKED OPEN. EBL 100 CC. 06/21/07: CENTRAL BAPTIST HOSPITAL. MICROBIOLOGY. CULTURE TISSUE WITH GRAM STAIN. ACCESSION: C1720862. SPECIMEN: TISSUE. SOURCE: ABDOMINAL. GRAM STAIN: MODERATE GRAM POSITIVE COCCI IN PAIRS AND GROUPS. ISOLATE: MODERATE GROWTH ***METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS***. 06/21/07: CENTRAL BAPTIST HOSPITAL. MICROBIOLOGY. CULTURE ANAEROBE. ACCESSION: C1720863. SPECIMEN: TISSUE. SOURCE: ABDOMINAL. ISOLATE: MODERATE GROWTH PREVOTELLA BIVIA (BACTEROIDES). 06/21/07: CENTRAL BAPTIST HOSPITAL. MICROBIOLOGY. CULTURE ROUTINE WITH GRAM STAI. ACCESSION: C1719290. SPECIMEN: ABSCESS. SOURCE: ADB WOUND ADCES [SIC]. GRAM STAIN: RARE WBC¿S, MANY RBC¿S, NO ORGANISMS SEEN. ISOLATE: LIGHT GROWTH, ***METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS*** REFER TO CULTURE C1720862 FOR SUSCEPTIBILITIES. 06/21/07: CENTRAL BAPTIST HOSPITAL. AFB CULTURES. CULTURE AFB W SMEAR. ACCESSION: C1720866. SPECIMEN: TISSUE. SOURCE: ABDOMINAL. AFB SMEAR: NO ACID FAST BACILLI SEEN ON CONCENTRATED SMEAR. ISOLATE: NO ACID FAST BACILLI ISOLATED. 06/21/07: CENTRAL BAPTIST HOSPITAL. FUNGAL CULTURES. CULTURE FUNGUS: ACCESSION: C1720884. SPECIMEN: TISSUE. SOURCE: ABDOMINAL. CULTURE RESULT: NO FUNGUS ISOLATED AT 6 WEEKS. FUNGAL GMS SMEAR: ACCESSION: C1720865. SPECIMEN: TISSUE. SOURCE: ABDOMINAL. GMS STAIN: NO FUNGAL ELEMENTS SEEN. 06/22/07: CENTRAL BAPTIST HOSPITAL. [ILLEGIBLE]. PROGRESS NOTES. S/P DRAINAGE OF ABDOMINAL ABSCESS. ABDOMINAL WOUND 3 X 20 CM X 16 CM X 7.5 CM WITH RED [ILLEGIBLE] WOUND BED WITH SPARSE YELLOW SLOUGH NOTED. NO ODOR. MESH NOTED ON TOP OF WOUND. NOTED MODERATE AMOUNT OF SEROSANGUINOUS DRAINAGE. 06/26/07: CENTRAL BAPTIST HOSPITAL. KC ETHINGTON ARNP. PROGRESS NOTE. MRSA ABD. WOUND INFX (MESH). 06/29/07: CENTRAL BAPTIST HOSPITAL. PETER TATE, MD. DISCHARGE SUMMARY. DIAGNOSIS: WOUND INFECTION. HISTORY: PRESENTED WITH AN INCARCERATED VENTRAL HERNIA COMPLEX SEVERAL WEEKS AGO REPAIRED WITH GORE-TEX MESH, NOW WITH INFECTION OF WOUND. EXAM: ABDOMEN; LARGE OPEN MIDLINE INCISION WITH PURULENT DRAINAGE, SOME REDNESS LOWER ABDOMEN. HOSPITAL COURSE: ADMITTED AND TAKEN TO OPERATING ROOM FOR DEBRIDEMENT. WOUND WAS OPENED UP, SKIN DEBRIDED, SOFT TISSUE DEBRIDED, AND OLD MESH WAS REMOVED AND REPLACED WITH PROLENE MESH, WHICH SHOULD GRANULATE. POSTOP DID WELL, NO COMPLICATIONS, TREATED WITH WOUND VAC, WILL BE DISCHARGE HOME ON THE SAME. 05/19/10: PAUL B. HALL REGIONAL MEDICAL CENTER. CULTURE ANAEROBIC AND AEROBIC. CULTURE ANAEROBIC FINAL REPORT: CORRECTED REPORT. RESULT 1: NO ANAEROBIC GROWTH IN 72 HOURS. CULTURE AEROBIC FINAL REPORT: RESULT 1: COAGULASE NEGATIVE STAPHYLOCOCCUS SPECIES. MODERATE GROWTH. 11/02/11: PAUL B. HALL REG MED CENTER. WOUND CARE HISTORY AND PHYSICAL. CC: ABSCESS FULL-THICKNESS ULCER OF RIGHT ABDOMEN OF 2 WEEKS DURATION. HPI: SEEN AT WOUND HEALING CENTER IN THE PAST FOR SURGICAL FULL-THICKNESS ULCER OF RIGHT UPPER HIP AND ABDOMEN. BOTH LESIONS WERE COMPLETELY HEALED WHEN SEEN ON JUNE 24, 2010 AND JUNE 17, 2010. LOCAL EXAMINATION: WOUND NUMBER 1, ABSCESS FULL-THICKNESS ULCER OF RIGHT ABDOMEN, MEASURES 0.8 X 0.8 X 2.7 WITH UNDERMINING 0.5 CM AT 10 TO 1 OCLOCK. NO ESCHAR. MINIMAL SLOUGH. WOUND BASE YELLOW AND PINK COLOR WITH HYPERGRANULATION. GRANULATION TISSUE PINK COLOR WITH HYPERGRANULATION. NO EXPOSED BONE, MUSCLE, OR TENDON. MILD ODOR. MODERATE AMOUNT OF PURULENT YELLOW SEROSANGUINEOUS DRAINAGE. NO EPITHELIUM. PERIWOUND INTEGRITY IS INTACT. TREATMENT AND PLAN: THE PATIENT IS TO HAVE WOUND CULTURE DONE OVER THE RIGHT ABDOMEN ULCER, AND THEN THE WOUND TO BE CLEANED WITH SALINE, APPLIED WITH LIDOCAINE 4 PERCENT GEL. 11/02/11: PAUL B. HALL REG MED CENTER. WOUND CARE OPERATIVE NOTE. PREOP DX: ABSCESS FULL-THICKNESS ULCER WITH UNDERMINING 0.5 CM AT 10 TO 1 OCLOCK, AND WOUND DEPTH OF 2.7 CM. POSTOP DIAGNOSIS: ABSCESS FULL-THICKNESS ULCER OF RIGHT ABDOMEN. PROCEDURE PERFORMED: CHEMICAL CAUTERIZATION USING SILVER NITRATE. ANESTHESIA: LIDOCAINE 5 PERCENT GEL. DESCRIPTION OF PROCEDURE: ¿WITH THE PATIENT IN SUPINE POSITION, FOLLOWING SALINE APPLICATION, THE WOUND CULTURE WAS DONE OVER THE ULCER AREA AND LIDOCAINE 5 PERCENT GEL APPLIED, THEN 1 STICK OF SILVER NITRATE WAS USED FOR CHEMICAL CAUTERIZATION. THE GRANULATION TISSUE AND WOUND EDGE TURNED GRAYISH COLOR. THE PATIENT FELT SLIGHT BURNING, BUT TOLERATED THE PROCEDURE WELL. THERE WERE NO COMPLICATIONS. NO BLEEDING. THE WOUND WAS DRESSED WITH AQUACEL AG, COVERED WITH 4X4 AND SECURED WITH TAPE. DRESSING TO BE CHANGED EVERY 48 HOURS. RETURN FOR FOLLOWUP IN 1 WEEK AND TAKE BOTH BACTRIM DS AND SPECTRACEF 400 MG B.I.D. THE PATIENT DID TAKE BACTRIM EARLIER AND ANTIBIOTICS RAN OUT. WE WILL CHECK WITH THE PATIENT OVER THE ORGANISM GROWTH FROM WOUND CULTURE THAT IS DONE TODAY, IN NEXT VISIT IN 1 WEEK.¿ 11/07/11: PHOTOS. WOUND 1B AND WOUND 2B [POOR QUALITY IMAGES]. 11/09/11: PAUL B. HALL REG MED CENTER. WOUND CARE HISTORY AND PHYSICAL. HX: CURRENTLY TAKING BACTRIM DS AND SPECTRACEF, IS TO CONTINUE, WILL NEED CAUTERIZATION WITH SILVER NITRATE AGAIN. EXAM: WOUND 1B, ABSCESS FULL-THICKNESS ULCER, RIGHT ABDOMEN, MEASURES 1 X 1.8 X 1.8. NO UNDERMINING. NO ESCHAR. NO SLOUGH. WOUND BASE RED COLOR. GRANULATION TISSUE PINK COLOR. NO EXPOSED BONE, MUSCLE, OR TENDON. NO ODOR. MODERATE AMOUNT OF SEROSANGUINEOUS DRAINAGE. LESS THAN 100 PERCENT EPITHELIUM. PERIWOUND INTEGRITY IS INTACT. IMPRESSION: RIGHT SIDE ABDOMEN, ABSCESS FULL-THICKNESS ULCER WITH STAPH INFECTION, CURRENTLY ON BACTRIM AND SPECTRACEF. MORBID OBESITY AND PREVIOUS ABDOMINAL WOUND INFECTION AT MESH AND DEBRIS, NOW HEALED. TREATMENT AND PLAN: THE PATIENT WILL NEED CHEMICAL DEBRIDEMENT USING SILVER NITRATE. WE WILL GIVE HER Z-PAK. CONTINUE BACTRIM AND SPECTRACEF. THE WOUND IS TO BE CAUTERIZED WITH SILVER NITRATE AND DRESSED WITH AQUACEL AG. 11/09/11: PAUL B. HALL REG MED CENTER. WOUND CARE OPERATIVE NOTE. PREOP DX: ABSCESS FULL-THICKNESS ULCER OF RIGHT SIDE ABDOMEN INFECTED WITH STAPH INFECTION, CURRENTLY ON BACTRIM AND SPECTRACEF. MORBID OBESITY. PREVIOUSLY UNDERWENT MULTIPLE ABDOMINAL SURGERIES AND HERNIA REPAIR, AND WAS TREATED WITH INFECTION OF MESH AND DEBRIDEMENT. THE WOUND HAS BEEN HEALED. POSTOPERATIVE DIAGNOSIS: ABSCESS FULL-THICKNESS ULCER OF RIGHT SIDE ABDOMEN. PROCEDURE: CHEMICAL DEBRIDEMENT USING SILVER NITRATE. ANESTHESIA: LIDOCAINE 5 PERCENT GEL. DESCRIPTION OF PROCEDURE: ¿WITH THE PATIENT IN SUPINE POSITION, THE WOUND AREA WAS CLEANED WITH SALINE, APPLIED WITH LIDOCAINE 5 PERCENT GEL, THEN DEBRIDEMENT BEGAN. USING ONE STICK OF SILVER NITRATE, THE WOUND BASE AND WOUND EDGE WERE TREATED WITH SLIVER NITRATE AND TURNED GRAYISH COLOR. THERE WAS NO BLEEDING. NO COMPLICATIONS. THE WOUND APPEARED TO BE MUCH SHALLOW. THE PATIENT TOLERATED WELL WITHOUT PAIN. THE WOUND THEN WAS DRESSED WITH AQUACEL AG, COVERED WITH 4X4 AND SECURED WITH TAPE. RETURN FOR FOLLOWUP IN 1 WEEK.¿ 11/16/11: PAUL B. HALL REG MED CENTER. WOUND CARE PROGRESS NOTE. HX: TODAY THE WOUND APPEARS CLEAN AND SHOWED PALE PINK GRANULATION TISSUE. GETTING SMALLER, NO HYPERGRANULATION, NO DEBRIDEMENT NEEDED. EXAM: ABDOMEN; WOUND NUMBER 1, RIGHT SIDE ABDOMEN FROM ABSCESS FULL-THICKNESS ULCER, MEASURES 1.2 X 1.7 X 1.5. NO ESCHAR. NO SLOUGH. WOUND BASE RED AND PALE PINK COLOR. GRANULATION TISSUE PINK COLOR AND RED COLOR. NO EXPOSED BONE, MUSCLE, OR TENDON. NO ODOR. MODERATE AMOUNT SEROSANGUINEOUS DRAINAGE. LESS THAN 100 PERCENT EPITHELIUM. IMPRESSION: ABSCESS FULL-THICKNESS ULCER, RIGHT SIDE ABDOMEN, AND WOUND INFECTED WITH STAPH AUREUS, CURRENTLY TAKING BACTRIM DS AND SPECTRACEF. MORBID OBESITY, PREVIOUSLY HAD GASTRIC BYPASS AND GAINED WEIGHT BACK. PREVIOUS WOUND INFECTION OVER THE MESH FROM HERNIA REPAIR. TREATMENT: THE PATIENT IS TO HAVE WOUND CLEANED WITH SALINE AND APPLIED WITH LIDOCAINE. THE WOUND TO BE DRESSED WITH AQUACEL AG PACKING TO RIGHT SIDE ABDOMEN ULCER, COVERED WITH 4X4 AND SECURED WITH TAPE. 11/23/11: PAUL B. HALL REG MED CENTER. WOUND CARE PROGRESS NOTE. HX: ABSCESS FULL-THICKNESS RIGHT SIDE ABDOMEN, 3 WEEKS DURATION WHEN SHE WAS SEEN ON NOVEMBER 9, 2011, UNDERWENT CHEMICAL CAUTERIZATION USING SILVER NITRATE. WOUND CULTURE GREW STAPHYLOCOCCUS AUREUS. GIVEN BACTRIM DS AND SPECTRACEF. UNDERWENT WOUND DEBRIDEMENT, APPEARS CLEAN AND PALE PINK, GETTING SMALLER AND HYPERGRANULATION. STILL ON BACTRIM WAS ADVISED TO FINISH BACTRIM, NEEDS SUBCUTANEOUS TISSUE DEBRIDEMENT OF WOUND AND THEN WILL REPEAT THE CULTURE. THERE IS A LOT OF DRAINAGE FROM THE WOUND. EXAM: ABSCESS RIGHT SIDE OF ABDOMEN, MEASURING 0.8 CM IN LENGTH, 1.4 CM IN WIDTH, 0.8 CM IN DEPTH. NO TUNNELING. NO UNDERMINING. NO ESCHAR. NO YELLOW SLOUGH FIBRIN. WOUND BASE COLOR IS RED. GRANULATION TISSUE IS PINK. NO EXPOSED TENDON OR BONE. NO ODOR. DRAINAGE COLOR IS SEROSANGUINEOUS. EPITHELIUM IS LESS THAN 100 PERCENT. 11/23/11: PAUL B. HALL REG MED CENTER. WOUND CARE OPERATIVE NOTE. PRE/POSTOP DIAGNOSIS: ABSCESS FULL-THICKNESS, RIGHT SIDE OF THE ABDOMEN. OPERATION: SUBCUTANEOUS TISSUE DEBRIDEMENT. DESCRIPTION OF PROCEDURE: ¿FIELD WAS PREPPED AND DRAPED IN USUAL MANNER, AFTER CLEANING WITH NORMAL SALINE, SUBCUTANEOUS TISSUE DEBRIDEMENT WAS DONE WITH A SMALL SHARP CURETTE. LARGE AMOUNT OF SEROSANGUINEOUS DISCHARGE WAS OBTAINED. THE PATIENT TOLERATED THE PROCEDURE WELL. SHE WAS ADVISED TO CONTINUE WITH BACTRIM AND REPEAT THE CULTURE NEXT WEEK.¿ 11/30/11: PHOTOS. WOUND 1B AND WOUND 2B [POOR QUALITY IMAGES.] 11/30/11: PAUL B. HALL REG MED CENTER. WOUND CARE HISTORY AND PHYSICAL. HX: SUBCUTANEOUS DEBRIDEMENT LAST WEEK. TAKING SPECTRACEF WITH BACTRIM DS. GETTING SMALLER, APPEARS HEALING. IN THE PAST WEEK, THE PATIENT CLEANED LARGE DIMPLE OVER HERNIA REPAIR, WHICH HAD THE WIRE MESH. FELT FOREIGN BODY PROTRUDING OUT, HAS STRONG ODOR. PMH: PREVIOUS UMBILICUS WOUND WAS TREATED WITH ANTIBIOTIC AND DEBRIDEMENT, NOW APPEARS TO HAVE WIRE MESH PROTRUDING AT THE LEFT SIDE OF THE CRATER OVER THE DIMPLE AREA. EXAM: ABDOMEN; WOUND 1B ABSCESS FULL-THICKNESS ULCER, RIGHT ABDOMEN, MEASURES 0.5 X 0.5 X 0.4 WITH UNDERMINING 0.2 CM AT 11 TO 1 OCLOCK. NO ESCHAR, MINIMAL SLOUGH. WOUND BASE YELLOW AND PALE PINK COLOR. GRANULATION TISSUE PINK COLOR. NO EXPOSED BONE, MUSCLE, OR TENDON. MILD ODOR WITH SCANTY SEROSANGUINEOUS DRAINAGE. LESS THAN 100 PERCENT EPITHELIUM. PERIWOUND INTEGRITY IS INTACT. WOUND 2, SURGICAL FULL THICKNESS ULCER OF LOWER MID ABDOMEN IN THE CRATER WITH PROTRUDING WIRE MESH LEFT SIDE. THE AREA MEASURES 1 X 0.3 X 0.1. NO ESCHAR, MINIMAL SLOUGH. WOUND BASE PALE PINK COLOR. GRANULATION TISSUE PINK COLOR. NO EXPOSED BONE, MUSCLE, OR TENDON WITH PROTRUDING WIRE MESH, MILD ODOR WITH SMALL AMOUNT OF SEROSANGUINEOUS DRAINAGE. PERIWOUND INTEGRITY IS INTACT. IMPRESSION: ABSCESS FULL-THICKNESS ULCER, RIGHT SIDE ABDOMEN, APPEARS HEALING AND SMALLER WOUND. SURGICAL FULL-THICKNESS ULCER OF LOWER MID ABDOMEN WITH PROTRUDING WIRE MESH AND CAUSING STRONG ODOR AND SMALL AMOUNT OF DRAINAGE. TREATMENT AND PLAN: THE PATIENT WILL NEED WOUND 1 DRESSED WITH AQUACEL AG TO THE RIGHT ABDOMEN ULCER, COVERED WITH 4X4 AND SECURED WITH TAPE, AND WOUND 3, THE WIRE MESH PROTRUDING OVER THE LOWER MID ABDOMEN, WILL NEED SUBCUTANEOUS DEBRIDEMENT WITH PARTIAL EXCISION OF THE WIRE MESH. THE WOUND ALSO TO BE DRESSED WITH AQUACEL AG, COVERED WITH 4X4 AND SECURED WITH TAPE, AND WOUND 2, THE WIRE MESH PROTRUDING OVER THE LOWER MID ABDOMEN, WILL NEED SUBCUTANEOUS DEBRIDEMENT WITH PARTIAL EXCISION OF THE WIRE MESH. THE WOUND ALSO TO BE DRESSED WITH AQUACEL AG, COVERED WITH 4X4 AND SECURED WITH TAPE. THE PATIENT TO CONTINUE BOTH BACTRIM DS AND SPECTRACEF 400 MG NEXT 10 DAYS, F/U 1 WEEK. WOUND CULTURE TO BE DONE AT RIGHT SIDE ABDOMEN SINCE THE PATIENT DID NOT TAKE ANTIBIOTICS FOR THE LAST FEW DAYS. RECORDS FOR ¿WOUND CULTURE¿ WERE NOT PROVIDED. 11/30/11: PAUL B. HALL REG MED CENTER. WOUND CARE OPERATIVE NOTE. PREOP DIAGNOSIS: SURGICAL FULL-THICKNESS ULCER OF LEFT MID ABDOMEN WITH PROTRUSION OF WIRE MESH AT LEFT LATERAL CRATER IN THE WOUND BASE. POSTOP DIAGNOSIS: SURGICAL FULL-THICKNESS ULCER, LEFT LOWER MID ABDOMEN WITH PROTRUDING FOREIGN BODY WIRE MESH. DESCRIPTION OF PROCEDURE: ¿WITH THE PATIENT IN SUPINE POSITION, THE WOUND OVER THE RIGHT SIDE ABDOMEN WAS CLEANED WITH SALINE, APPLIED WITH AQUALCEL AG AND COVERED WITH 4X4 AND SECURED WITH TAPE, THEN AT THE OPERATIVE SITE LOWER MID ABDOMEN SURGICAL FULL-THICKNESS ULCER WITH WIRE MESH AT THE LEFT SIDE OF THE CRATER, THE FORCEPS WAS USED WITH SCISSORS AND THE WIRE MESH WAS GRASPED AND THEN EXCISED DOWN TO THE WOUND EDGE. THERE WAS SLIGHT BLEEDING. THE WOUND BASE APPEARED CLEAN AND NO WIRE MESH SEEN. THE PATIENT HAS NO PAIN. FOREIGN BODY WAS REMOVED, AND NOT ABLE TO BE GRABBED AT THE WOUND SURFACE OF THE WOUND BASE, AND THERE WAS NO COMPLICATION. BLEEDING WAS EASILY CONTROLLED WITH GAUZE AND PRESSURE. THE WOUND WAS THEN APPLIED WITH AQUACEL AG, COVERED WITH 4X4 AND SECURED WITH TAPE. THE PATIENT TOLERATED THE PROCEDURE WELL. SHE IS TO CONTINUE TAKING BOTH BACTRIM DS AND SPECTRACEF IN NEXT 10 DAYS. RETURN FOR FOLLOWUP IN 1 WEEK.¿ RECORDS FOR ¿WOUND CULTURE¿; ¿NO GROWTH¿ WAS NOT PROVIDED. 12/07/11: PAUL B. HALL REG MED CENTER. WOUND CARE PROGRESS NOTE. HX: LAST WEEK, EXPOSED WIRE MESH DEBRIDEMENT, EXCISION FOREIGN BODY DONE WITH SLIGHT BLEEDING, WOUND CULTURE DONE. SILVER NITRATE CAUTERIZATION USED, CONTINUED ON SPECTRACEF WITH BACTRIM DS. THE WOUND CULTURE NO GROWTH. WOUND OVER RIGHT ABDOMEN COMPLETELY HEALED, SCAB FORMING. EXAM: WOUND 1B, ABSCESS FULL-THICKNESS ULCER, RIGHT SIDE ABDOMEN, MEASURES 0 X 0 X 0, COMPLETELY HEALED WITH 100 PERCENT FULLY COVERED WITH EPITHELIUM AND SCAB FORMATION. WOUND 2B , LOWER MID ABDOMEN SURGICAL FULL-THICKNESS ULCER, 1 WEEK POST WIRE MESH DEBRIDEMENT AND TREATED WITH SILVER NITRATE CAUTERIZATION, MEASURES 0 X 0 X 0 AND NO DRAINAGE, APPEARS HEALED. IMPRESSION: COMPLETELY HEALED ABSCESS FULL-THICKNESS ULCER OF RIGHT SIDE ABDOMEN AND SURGICAL FULL-THICKNESS ULCER OF LOWER MID ABDOMEN, POST WIRE MESH DEBRIDEMENT, NEGATIVE WOUND CULTURE. TREATMENT AND PLAN: DESITIN APPLIED OVER LOWER MID ABDOMEN. KEEP BOTH WOUNDS OPEN. 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.
(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 VENTRAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY A GORE® DUALMESH® PLUS 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: MESH INFECTION, PAIN, ABDOMINAL ABSCESS, DEBRIDEMENT, MESH REMOVAL, ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 484420 | GORE DUALMESH PLUS BIOMATERIAL | MESH, SURGICAL, POLYMERIC | FTL | W.L. GORE & ASSOCIATES | 1DLMCP04 | 04473908 | 00733132601110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| R |