GORE DUALMESH BIOMATERIAL

MDR report key: 8692240 · Received June 12, 2019

Report

Report Number: 2017233-2019-00410
Event Type: Injury
Date Received: June 12, 2019
Date of Event: August 3, 2017
Report Date: July 23, 2021
Manufacturer: W.L. GORE & ASSOCIATES
Product Code: FTL
UDI-DI: 00733132600960
PMA / PMN Number: K992189
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

H6: UPDATED RESULT CODE. CONCLUSION CODE REMAINS UNCHANGED.

Additional Manufacturer Narrative · 0

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: RECORDS PRIOR TO (B)(6) 2005, INCLUDING ANY PREVIOUS ABDOMINAL SURGICAL PROCEDURES, WERE NOT PROVIDED. (B)(6) 2005: (B)(6) HOSPITAL. (B)(6), MD. EMERGENCY DEPARTMENT H&P. HPI: C/O PERIUMBILICAL AND LOWER ABDOMINAL PAIN, NAUSEA, CRAMPING SINCE YESTERDAY. NO DIARRHEA, VOMITING, FEVER. EXAM: ABDOMEN; POSITIVE BOWEL SOUNDS, SOFT, NONTENDER. PELVIC ULTRASOUND SHOWED CYST RIGHT OVARY. IMPRESSION: ACUTE ABDOMINAL CRAMPS, GASTROENTERITIS. (B)(6) 2005: (B)(6) HOSPITAL. (B)(6), MD. RADIOLOGY-US ABDOMEN/PELVIS. IMPRESSION: ABDOMEN NEGATIVE. PELVIC; HYSTERECTOMY, 1.8 CM RIGHT ADNEXAL MASS. RECORDS BETWEEN 3/21/2005 AND 8/6/2007 WERE NOT PROVIDED. (B)(6) 2007: (B)(6) HOSPITAL. (B)(6), MD. EMERGENCY DEPARTMENT H&P. HPI: C/O SUPRAPUBIC ABDOMINAL PAIN, DYSURIA, URGENCY, BACK PAIN. TELLS ME SHE HAD SWELLING ON THE RIGHT SIDE OF ABDOMEN, NOT THERE NOW. EXAM: ABDOMEN; FULL, SOFT, OTHERWISE BENIGN. DO NOT SEE ANY MASSES. THIS FULLNESS AND BULGING SHE TALKS ABOUT IS NOT THERE. IMPRESSION: ABDOMINAL PAIN NOS. (B)(6) 2007: (B)(6) HOSPITAL. (B)(6), MD. RADIOLOGY-US ABDOMEN. DX: ABDOMINAL WALL PAIN, POSSIBLE HERNIA. HX: SURGERY SEVERAL YEARS AGO HAS TENDERNESS WITH SUPERFICIAL MASS ALONG SCAR ANTERIORLY. IMPRESSION: ANTERIOR ABDOMINAL WALL HERNIA AT PREVIOUS SURGICAL SITE. THE HERNIA IS SEEN TO ENLARGE SOMEWHAT WITH VALSALVA. APPEARS TO CONTAIN MESENTERIC FAT; NO EVIDENCE OF BOWEL LOOPS WITHIN HERNIA. [MISSING RECORDS: RECORDS INCLUDING OP REPORT DETAILING IMPLANTATION OF AND TYPE OF MESH PRIOR TO (B)(6) 2007 SURGERY WERE NOT PROVIDED.] (B)(6) 2007: (B)(6) HOSPITAL. (B)(6), MD. OPERATIVE REPORT. PREOP DIAGNOSIS: RECURRENT VENTRAL HERNIA. POSTOP DIAGNOSIS: FINDINGS OF PARTIAL SMALL BOWEL OBSTRUCTION AND MULTIPLE ADHESIONS, RECURRENT VENTRAL HERNIA WITH INVOLVED SURGICAL MESH. PROCEDURE: REPAIR OF RECURRENT VENTRAL HERNIA. LYSIS OF ADHESIONS. REDUCTION OF PARTIAL SMALL BOWEL OBSTRUCTION. PARTIAL OMENTECTOMY. REMOVAL OF SURGICAL MESH. PROCEDURE IN DETAIL: ¿PATIENT WAS TAKEN TO THE OPERATING ROOM AND PLACED IN THE SUPINE POSITION. AFTER ADEQUATE GENERAL ENDOTRACHEAL ANESTHESIA, THE ABDOMEN WAS PREPPED AND DRAPED IN STERILE FASHION. INCISION WAS MADE STARTING FROM ABOVE THE MASS IN THE ABDOMEN. THE INCISION WAS CARRIED DOWN TO THE DEEP TISSUES WITH METZENBAUM SCISSORS AND A LARGE HERNIA SAC WAS LOCALIZED AND OPENED AND INSPECTED AND INCARCERATED. THE PATIENT HAD TEDIOUS OPENING OF THE ABDOMINAL WALL BECAUSE OF MULTIPLE ADHESIONS AND SMALL VENTRAL HERNIAS INVOLVING THE PRIOR SURGICAL MESH. THE WOUND WAS ELEVATED WITH CLAMPS AND MULTIPLE ADHESIONS WERE TAKEN DOWN AT THE ANTERIOR ABDOMINAL WALL. THERE WAS COPIOUS OMENTUM INCARCERATED WITHIN THE HERNIA SAC AND PARTIAL OMENTECTOMY WAS UNDERTAKEN TO FREE THIS OMENTUM AS WELL AS TO FREE PARTIALLY-OBSTRUCTED SMALL BOWEL INVOLVED IN THE HERNIA ITSELF. THE PATIENT ALSO HAD REMOVAL OF SOME SURGICAL MESH INVOLVED IN THE HERNIA DEFECT AND ALSO REMOVED FOR FACILITY OF CLOSURE. THE OMENTECTOMY WAS UNDERTAKEN WITH 0 VICRYL LIGATURES AND IT WAS POSSIBLE THEN TO FREE THE SMALL BOWEL AND OMENTUM FROM THE HERNIA DEFECT. THE MARGINS WERE CLEARED CIRCUMFERENTIALLY AND THE WOUND WAS ABLE TO BE CLOSED WITH MULTIPLE #1 PDS SUTURES IN A FIGURE-OF-EIGHT FASHION. THE SKIN WAS CLOSED WITH STAPLES. THE PATIENT TOLERATED THE PROCEDURE WELL. ESTIMATED BLOOD LOSS ¿ APPROXIMATELY 20 CC. SPONGE AND NEEDLE COUNTS WERE CORRECT.¿ (B)(6) 2007: (B)(6) HOSPITAL. INTRAOPERATIVE RECORD. IMPLANT LABEL. IMPLANT/EXPLANTS: OR DESCRIPTION; MESH PROLENE 3 X 6 PM. MANUFACTURER: 4469. TYPE: IMPLANT. QTY: 1. (B)(6) 2007: (B)(6) HOSPITAL. (B)(6), MD. DISCHARGE SUMMARY. DISCHARGE DX: S/P REPAIR OF VENTRAL HERNIA. HOSPITAL COURSE: UNREMARKABLE. OBSERVED AND TOLERATING CLEAR LIQUID DIET; ADVANCED TO REGULAR DIET WITHOUT DIFFICULTY. DISCHARGED HOME AFTER REPAIR OF INCISIONAL HERNIA WHICH WAS INCARCERATED. NO COMPLAINTS AT TIME OF DISCHARGE. (B)(6) 2007: (B)(6) CENTER. (B)(6), MD. HPI: ABDOMINAL WOUND. HERNIA REPAIR (B)(6) 2007 FIRST NOTICED OOZING IMMEDIATELY AFTER STAPLES REMOVED ON (B)(6) 2017. DRAINAGE INCREASED, BECAME MALODOROUS. WOUND LOCATED ON NAVEL PRESENT FOR APPROX 2 WEEKS. SCORES PAIN AS (B)(6) 2017. MODERATE AMOUNT SEROSANGUINEOUS AND MALODOROUS EXUDATE DRAINING FROM WOUND; WOUND BED HAS EXPOSED SUBCUTANEOUS TISSUE. PERI-WOUND SKIN IS ERYTHEMATOUS, EDEMATOUS AND TENDER TO PALPATION. PLAN FOR WOUND IS APPLY AMD GAUZE 2-3 TIMES PER WEEK FOR ONE MONTH. WT. 271, BMI 45.1. IMPRESSION: NON-HEALING SURGICAL WOUND. INFECTED SEROMA WITH POCKET EXTENDING 7-8 CM ABOVE THE UMBILICUS AND DRAINING THROUGH THE UMBILICUS. WE DECOMPRESSED THE POCKET AND WICKED A PACKING STRIP IN THERE. STARTED ON BACTRIM. (B)(6) 2007: (B)(6) HOSPITAL. MICROBIOLOGY-WOUND CULTURE. CULTURE, WOUND + ANAEROBE. SPECIMEN: ABDOMEN SWAB. CULTURE WITH SENSITIVITY. RESULT: 1. 1+ GROWTH STAPHYLOCOCCUS AUREUS. 2. CONTACT SRH MICRO LAB WITHIN 48 HOURS AFTER FINAL DATE, IF CLINDAMYCIN RESULTS NEEDED. ADDITIONAL TESTING IS REQUIRED AFTER RECEIPT OF REQUEST. (B)(6) 2007: (B)(6) CENTER. (B)(6), MD. PROGRESS NOTE. DX: NON-HEALING SURGICAL WOUND. EXAM: ABDOMEN; FRESH, HEALING MIDLINE INCISION. IMPRESSION: UMBILICAL DRAINAGE DECREASING IN VOLUME. PROBED UMBILICUS WITH RESULTANT DRAINAGE OF PURULENT MATERIAL WHICH WAS CULTURED. GOOD RELIEF OF PRESSURE DISCOMFORT. DEFECT IS IN THE DEEP UMBILICAL SKIN AND FASCIA IS INTACT. WILL TREAT W/ PULSE LAVAGE, AMD PACKING DAILY. STARTED ON LEVAQUIN AND FLAGYL PENDING CULTURES. APPEARANCE: MODERATE AMOUNT OF MALODOROUS AND YELLOW EXUDATE. FULL-THICKNESS WOUND W/EXPOSED SUBCUTANEOUS. PERI-WOUND INDURATED. PAIN 10/10. (B)(6) 2007: (B)(6) MEDICINE CENTER. (B)(6), MD. PROGRESS NOTE. DX: NON-HEALING SURGICAL WOUND. IMPRESSION: BECAUSE OF PERSISTING FOUL ODOR OF DRAINAGE, WE CHANGED TO DAKINS. WE¿LL USE 0.25% FOR COUPLE OF DAYS THEN DROP TO 0.125 UNDIL [SIC] WE SEE IMPROVEMENT. ON TODAY¿S PULSE LAVAGE WE GOT THE TIP INTO THE CAVITY AND WASHED OUT A LOT OF THICK BROWN MATERIAL THAT LOOKS LIKE SAND IN BOTTOM OF CANNISTER. HOPEFULLY, THIS APPROACH ALONG WITH ANTIBIOTICS WILL LET THIS TRACK HEAL WITHOUT NEED FOR FURTHER SURGERY. (B)(6) 2007: (B)(6) MEDICINE CENTER. (B)(6), MD. PROGRESS NOTE. DX: NON-HEALING SURGICAL WOUND. IMPRESSION: VENTRAL HERNIA WOUND HAS HEALED NICELY W/ PULSE LAVAGE. WILL CONVERT TO CLEANSING, F/U 1 WEEK. APPEARANCE: MINIMUM AMOUNT OF SEROSANGUINEOUS EXUDATE. PARTIAL THICKNESS WOUND. PERI-WOUND INDURATED. PAIN: 10/10. (B)(6) 2007: (B)(6) MEDICINE CENTER. (B)(6), MD. PROGRESS NOTE. DX: NON-HEALING SURGICAL WOUND. IMPRESSION: WOUND WAS OVERPACKED AND THAT IS HELPING TO KEEP IT OPEN. THERE IS NO INFECTION. WE CUT PACKING STRIPS OF APPROPRIATE SIZE AND WILL CHECK BACK IN FEW DAYS. APPEARANCE: MODERATE AMOUNT OF MALODOROUS EXUDATE. FULL-THICKNESS WOUND W/ EXPOSED SUBCUTANEOUS. PERI-WOUND NORMAL. PAIN: 10/10. (B)(6) 2008: (B)(6) HOSPITAL SYSTEM. (B)(6), MD. EMERGENCY DEPARTMENT H&P. CC: ABDOMINAL PAIN. HPI: INCREASING ABDOMINAL PAIN IN UPPER ABDOMEN GOING ON FOR MORE THAN 2 WEEKS. DENIES FEVER OR VOMITING, GOOD APPETITE. EXAM: GASTROINTESTINAL; ABDOMEN SOFT, NORMOACTIVE BOWEL SOUNDS. POSITIVE TENDERNESS IN MID UPPER ABDOMEN ABOVE PREVIOUS SURGICAL INCISION. THERE IS PALPATED MASS IN THIS AREA, LIKELY HERNIA. CT ABD/PELVIS DOES REVEAL VENTRAL HERNIA WITH A LOOP OF INTESTINE, BUT NO EVIDENCE OF OBSTRUCTION. IMPRESSION: VENTRAL HERNIA. PLAN: F/U WITH GENERAL SURGERY, DR. (B)(6) ON MONDAY. (B)(6) 2008: (B)(6) HOSPITAL. (B)(6), MD. RADIOLOGY-CT ABDOMEN/PELVIS W/ CONTRAST. IMPRESSION: HX OF RECENT HERNIA REPAIR BUT W/ PERSISTENT MIDLINE ABDOMINAL WALL HERNIA CONTAINING A LOOP OF SMALL BOWEL SHOWING NO ADDITIONAL COMPLICATION. OTHERWISE NORMAL CT SCAN OF ABD/PELVIS. (B)(6) 2008: (B)(6) HEALTH SYSTEM. (B)(6), MD. H&P. HPI: RETURNS AFTER DR. HORAN PERFORMED RESECTION OF MESH AND REPAIR OF A MULTIPLY RECURRENT INCISIONAL HERNIA ON (B)(6) 2007. AT THAT TIME, HAD SMALL PARTIAL BOWEL RECONSTRUCTION, PARTIAL OMENTECTOMY AS WELL. PRIMARILY REPAIRED THE HERNIA W/ PDS. HERNIA HAS RECURRED, WAS RECENTLY IN ED WITH CT SCAN THAT DEMONSTRATED A LOOP OF BOWEL WITHIN THE HERNIA; CURRENTLY NOT OBSTRUCTED. C/O MINIMAL TENDERNESS AROUND HERNIA ITSELF. EXAM: OBESE, WEIGHS 277 LBS. ABDOMEN; SIGNIFICANT FOR A CHRONICALLY INCARCERATED HERNIA AT UMBILICUS. IMPRESSION: MULTIPLE RECURRENT INCISIONAL HERNIA. PLAN: GOING TO BE DIFFICULT REPAIR. SHE IS VERY OBESE, AND HER RISKS FOR RECURRENCE OR WOUND COMPLICATIONS ARE SIGNIFICANT. WHAT SHE NEEDS IS PLACEMENT OF GORE-TEX DUALMESH IN A RETRO-FASCIAL LOCATION, AND THIS WILL HAVE TO BE A LARGE PIECE OF GORE-TEX DUALMESH. I HAVE COUNSELED HER ON NEED FOR WEIGHT LOSS. PLAN TO PROCEED AT SINGING RIVER HOSPITAL. SHE UNDERSTANDS IF SHE DEVELOPS VOMITING OR ABDOMINAL PAIN BETWEEN NOW AND TIME WE PLAN TO REPAIR HERNIA, CALL IMMEDIATELY; WILL ADMIT AND REPAIR HERNIA SOONER. (B)(6) 2008: (B)(6) HOSPITAL. (B)(6), MD. OPERATIVE REPORT. PRE/POSTOP DIAGNOSIS: MULTIPLE RECURRENT INCARCERATED INCISIONAL HERNIAS. OPERATION: REPAIR OF INCARCERATED INCISIONAL HERNIAS WITH GORE-TEX DUALMESH. LIMITED EXPLORATORY LAPAROTOMY. LYSIS OF ADHESIONS. FINDINGS: MULTI-PARTITE DEFECT IN THE UPPER ABDOMINAL FASCIA WITH SMALL BOWEL AND OMENTUM INCARCERATED WITHIN IT. THERE WERE NUMEROUS DENSE, INTRAABDOMINAL ADHESIONS. INDICATIONS FOR PROCEDURE: ¿THE PATIENT IS A 43-YEAR-OLD FEMALE STATUS POST MESH AND PRIMARY REPAIR OF MULTIPLE RECURRENT INCISIONAL HERNIAS. I RECOMMENDED MESH REPAIR.¿ PROCEDURE IN DETAIL: ¿THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND PLACED IN THE SUPINE POSITION. AFTER ADEQUATE GENERAL ANESTHESIA, THE ABDOMEN WAS PREPPED AND DRAPED IN THE NORMAL STERILE FASHION. A MIDLINE INCISION WAS MADE WITH A KNIFE AND CARRIED DOWN THROUGH THE SUBCUTANEOUS TISSUES WITH BOVIE CAUTERY. THE UPPER ABDOMINAL FASCIA WAS DISSECTED FIRST WHERE THERE WERE NO PRIOR INCISIONS. THE FASCIA WAS VERY THIN HERE, BUT OTHERWISE HEALTHY. THE FASCIA WAS DIVIDED AND EXPOSURE WAS GAINED INTO THE PERITONEAL SPACE. I THEN PROCEEDED TO DISSECT THE HERNIA SAC OUT AND REDUCE IT BACK INTO THE ABDOMEN. IT WAS INCARCERATED. SEVERAL SMALL DEFECTS WERE JOINED TO MAKE A LARGER DEFECT BY DIVIDING THE BANDS AND SEPARATING THEM. SHARP DISSECTION ONLY WAS USED TO MOBILIZE THE SMALL BOWEL AND OMENTUM BACK INTO THE ABDOMEN AND AFTER DISSECTING OUT THE ANTERIOR ABDOMINAL WALL IN THIS AREA, CIRCUMFERENTIALLY, PROXIMALLY 4 CM BEYOND THE HEALTHY FASCIAL EDGE. I THEN SEWED IN A PIECE OF GORE-TEX DUALMESH WITH INTERRUPTED 0 ETHIBOND TRANSFACIAL [SIC] SUTURES. WITH THE SMOOTH SIDE DOWN, TOWARD THE BOWEL. A 10 X 15 CM PIECE OF GORE-TEX DUALMESH WAS USED. NEXT, THE WOUND WAS IRRIGATED THOROUGHLY. #1 DOUBLE LOOP PDS WAS USED TO CLOSE THE FASCIA OVER THE GORE-TEX DUALMESH. A 19 FRENCH BLADE [SIC] DRAIN WAS PLACED. THE SUBCUTANEOUS TISSUE WAS CLOSED WITH 3-0 VICRYL. THE SKIN WAS CLOSED WITH STAPLES. THE PATIENT TOLERATED THE PROCEDURE WELL.¿ (B)(6) 2008: (B)(6) HOSPITAL. PERIOPERATIVE RECORD. IMPLANT RECORD. DESCRIPTION: MESH DUAL PLUS 10 X 15 CM. LOT#: 03158621. CATALOG: 1DLMC03. QUANTITY: 1. SITE: ABDOMEN. MANUFACTURER: GORE W L & ASSOC INC. (B)(6) 2008: (B)(6) HOSPITAL SYSTEM. PROGRESS NOTES. IMPLANT STICKER. DUALMESH BIOMATERIAL. LOT: 03158621. ITEM: 1DLMC03. THE RECORDS CONFIRM A GORE® DUALMESH® BIOMATERIAL (1DLMC03/03158621) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 2008: (B)(6) HOSPITAL SYSTEM. (B)(6), MD. PATHOLOGY REPORT. SPECIMEN #: (B)(6). SOURCE: A. HERNIA SAC. CLINICAL DIAGNOSIS: VENTRICULAR INCISIONAL HERNIA. GROSS DESCRIPTION: RECEIVED IS A FRAGMENT OF FIBRO-FATTY TISSUE WHICH MEASURES 3.5 X 2.0 X 0.5 CM. ALONG ONE SIDE OF THIS TISSUE FRAGMENT THERE APPEARS TO BE A SMOOTH GLISTENING MEMBRANE. TWO REPRESENTATIVE SECTIONS ARE SUBMITTED. FINAL DIAGNOSIS: SOFT TISSUE, HERNIORRHAPHY#-SOFT TISSUE CONSISTENT WITH HERNIA SAC. (B)(6) 2008: SINGING RIVER HOSPITAL. KIM GRAY, PA-C/EDWARD I. (B)(6) , MD. DISCHARGE SUMMARY. ADMIT/DISCHARGE DX: VENTRAL HERNIA. SUMMARY: ADMITTED (B)(6) 2008 AFTER VENTRAL HERNIA REPAIR W/MESH. DID WONDERFUL OVERNIGHT; REMAINED AFEBRILE, WAS TOLERATING A REGULAR PO DIET, ADEQUATE PAIN CONTROL, AMBULATING WELL. J-VAC DRAIN PULLED PRIOR TO DISCHARGE. F/U WITH DR. (B)(6) IN APPROX. 1-2 WEEKS. PERCOCET FOR PAIN CONTROL. DISCHARGED IN STABLE CONDITION. (B)(6) 2008: (B)(6) HOSPITAL. (B)(6), MD. EMERGENCY DEPARTMENT H&P. HPI: C/O LOWER ABDOMINAL PAIN; SYMPTOMATIC FOR WEEK. SHARP PAIN JUST UNDER SCAR FROM RECENT INCISION HERNIA REPAIR. OUT OF PAIN MEDICINE, DENIES FEVER, HAS NAUSEA NO VOMITING OR DIARRHEA. EXAM: TEMP. 100.1. ABDOMEN; OBESE, TENDERNESS UNDERNEATH SCAR FROM RECENT SURGERY, NO SIGN OF DEHISCENCE OR INFECTION. CT ABD/PELVIS NEGATIVE. IMPRESSION: PROBABLY STRESSED SCAR TISSUE. REFILL PERCOCET. (B)(6) 2008: (B)(6) HOSPITAL. (B)(6), MD. RADIOLOGY-XR ABDOMEN 2V, KUB. HX: ABDOMINAL PAIN. IMPRESSION: BENIGN APPEARING ABDOMEN. (B)(6) 2008: (B)(6) HOSPITAL. (B)(6), MD. RADIOLOGY-CT ABDOMEN/PELVIS W/CONTRAST. HX: RECENT ANTERIOR ABDOMINAL WALL HERNIA REPAIR; CONTINUED PAIN. COMPARISON: 04/04/08. ANTERIOR ABDOMINAL WALL HERNIA HAS BEEN PERFORMED WITH MESH PLATES. THIS IS THE RESULT OF THE DEFECT PREVIOUSLY DEMONSTRATED. IMPRESSION: PRIOR ANTERIOR ABDOMINAL WALL HERNIA REPAIR WITHOUT COMPLICATION OR RECURRENCE. OTHERWISE UNREMARKABLE CT SCAN. RECORDS BETWEEN 7/10/2008 AND 10/17/2012 WERE NOT PROVIDED. (B)(6) 2012: (B)(6) HOSPITAL. (B)(6), MD. ED NOTES. HPI: DISCOMFORT TO ABDOMEN LAST COUPLE DAYS. MEDICATIONS: ASPIRIN. SOCIAL HX: NEVER SMOKER, NO ALCOHOL. EXAM: WT. 261 LB, BMI 43.43. GI: BOWEL SOUNDS NORMAL, SOFT, MILD DIFFUSE TENDERNESS, NO MASSES. IMPRESSION: CHRONIC BACK PAIN. ABDOMINAL PAIN. EXPECTANT TREATMENT WITH ANTACID. (B)(6) 2013: (B)(6) HOSPITAL. (B)(6), MD. ED NOTES. HPI: ABDOMINAL PAIN; RLQ X4 DAYS. NO F/N/V OR DIARRHEA. NORMAL APPETITE. WORSE W/CERTAIN MOVEMENTS. MEDICATIONS: [INCLUDED] ASPIRIN. EXAM: GI; BOWEL SOUNDS NORMAL, SOFT, MILD RLQ TENDERNESS, NO MASSES. WT.: 260 LB, BMI: 43.27. IMPRESSION: UTI. ABDOMINAL PAIN RLQ. (B)(6) 2013: (B)(6) HOSPITAL. (B)(6), MD. ED NOTES. HPI: COUGH STARTED YESTERDAY, WORSENED TODAY. ONE EPISODE OF VOMITING AFTER COUGHING SPELL. DENIES ABDOMINAL PAIN. EXAM: GI; BOWEL SOUNDS NORMAL, SOFT, NO TENDERNESS, MASSES OR PERITONEAL SIGNS. PREDNISONE GIVEN. RX: MEDROL DOSE PACK, TAMIFLU. IMPRESSION: INFLUENZA A, ASTHMA. (B)(6) 2014: (B)(6) HOSPITAL. (B)(6), MD. ED NOTES. HPI: COUGH AND ABDOMINAL PAIN. ABDOMINAL PAIN ACHING, INTERMITTENT AND EXACERBATED BY COUGHING AND CERTAIN MOVEMENTS. STATES COUGH PRECEDED ABDOMINAL PAIN, BELIEVES IT MAY BE THE CAUSE OF IT. DENIES FEVER, CHILLS, NAUSEA, VOMITING OR DIARRHEA. WT.: 265 LB, BMI: 44.1. EXAM: OBESE. GI; BOWEL SOUNDS NORMAL, SOFT, MILD TENDERNESS THROUGHOUT, NO MASSES, PERITONEAL SIGNS OR GUARDING. ALBUMIN 3.3 (L). IMPRESSION: ACUTE BRONCHITIS, HX CHF. (B)(6) 2014: (B)(6) HOSPITAL. (B)(6), MD. ED NOTES. CC: ABDOMINAL PAIN; UPPER ABD BUT RADIATES TO LOWER ABD, STARTED 2 DAYS AGO. NAUSEA/VOMITING/DIARRHEA; STARTED YESTERDAY. HPI: C/O RATHER DIFFUSE ABDOMINAL PAIN. NO FEVER. CANNOT LOCALIZE THE PAIN ALTHOUGH IT SEEMS MORE INTENSE ACROSS UPPER ABDOMEN. EXAM: ABDOMEN; SOFT, NONDISTENDED, NO SPECIFIC AREA OF TENDERNESS OR SORENESS TO PALPATION BUT RATHER ENTIRE ABDOMEN IS SORE TO PALPATION, MOSTLY ACROSS UPPER ABDOMEN. IMPRESSION: ABDOMINAL PAIN. (B)(6) 2014: (B)(6) HOSPITAL. (B)(6), MD. ED NOTES. HPI: C/O LEFT HIP PAIN, MID ABDOMINAL PAIN. NO FEVER, VOMITING OR DIARRHEA; HAS HAD NAUSEA. HAS BAD HIP PROBLEM; WHEN SHE ¿FAVORS THAT HIP, IT CAUSES HER STOMACH TO HURT, SHE¿S HAD MULTIPLE HERNIA SURGERIES ON HER STOMACH.¿ WT: 253 LB, BMI: 42.1. EXAM: GI; BOWEL SOUNDS NORMAL, SOFT, TENDER TO PALPATION ALONG MIDLINE SURGICAL SCAR, NO MASSES. GU; NO HERNIA NOTED. X-RAYS OF ABDOMEN WITHOUT AIR FLUID LEVELS OR FREE AIR. IMPRESSION: SOME ABDOMINAL SCARRING FROM HERNIA REPAIRS; COULD CERTAINLY BE SCAR TISSUE RELATED PAIN; HAS H/O CHRONIC PAIN ISSUES. UTI. (B)(6) 2014: (B)(6) HOSPITAL. (B)(6), MD. RADIOLOGY-XR ABDOMEN, 1 VIEW (KUB). HX: PAIN. IMPRESSION: BENIGN-APPEARING UPRIGHT ABDOMEN. (B)(6) 2014: (B)(6) HOSPITAL. (B)(6), MD. ED NOTES. CC: ABDOMINAL PAIN; HAS A ¿BAD CATCH IN ABD¿ WORSE WHEN COUGHING OR TURNING TO RIGHT SIDE. HPI: REPORTS OCCASIONALLY, FOR SEVERAL MONTHS, WILL GET SHARP PAIN IN ABDOMEN. NO ASSOCIATED FEVER, VOMITING, DIARRHEA. BOWEL MOVEMENTS OCCASIONALLY IRREGULAR. ROS: OCCASIONAL RIGHT SIDED ABD PAIN; SHARP, LASTS FEW SECONDS. EXAM: GI; BOWEL SOUNDS NORMAL, SOFT, NO TENDERNESS ON PALPATION, NO MASSES. IMPRESSION: COUGH, INTERMITTENT RIGHT SIDED ABDOMINAL PAIN. INSTRUCTED ON INCREASING FIBER IN DIET TO SEE IF PAIN ANYTHING TO DO WITH INTESTINAL CRAMPING AND CONSTIPATION. RECORDS BETWEEN 11/22/2014 AND 8/16/2016 WERE NOT PROVIDED. (B)(6) 2016: (B)(6) HOSPITAL. (B)(6), DO. ED NOTES. HPI: PRESENTS FOR REPORTED PERIUMBILICAL AREA ABDOMINAL PAIN ALONG W/ REPORTED DRAINAGE AROUND BELLYBUTTON. SYMPTOMS PRESENT PAST 3-4 YEARS SINCE PRIOR SURGERY. SLOWLY WORSENING OVER TIME; HAS NOT FOLLOWED UP RECENTLY W/ SURGEON. NO ACUTE TRAUMA, FEVER, CHILLS, NAUSEA, VOMITING OR DIARRHEA. NO BLEEDING FROM AREA. EXAM: GI; SOFT, MINIMAL PERIUMBILICAL AREA TENDERNESS WITHOUT GUARDING OR DISTENTION. VERY SMALL AMOUNT OF DRAINAGE FROM UMBILICUS; NO ACTIVE BLEEDING. NO FLUCTUANCE OR ERYTHEMA NOTED AROUND ABDOMEN. IMPRESSION: PERIUMBILICAL ABD PAIN, DRAINING POSTOP WOUND, INITIAL ENCOUNTER. RX: CLINDAMYCIN TO TREAT POSSIBLE MILD WOUND INFECTION; SUSPECT SIGNIFICANT DEEP SPACE ABSCESSES BASED ON HX AND EXAM. (B)(6) 2016: (B)(6) HOSPITAL. (B)(6), MD. RADIOLOGY-CT ABD/PELVIS W/CONTRAST. HX: F/U HERNIA REPAIR SURGERY. COMPARISON: (B)(6) 2008. IMPRESSION: CHANGES OF PRIOR ANTERIOR ABDOMINAL WALL HERNIA REPAIR. CAUDAL TO THE NASH [SIC], IS AN UMBILICAL HERNIA THAT CONTAINS SOFT TISSUE DENSITY NOT REPRESENTING FAT NOR OPACIFIED SMALL BOWEL. OTHERWISE NONSPECIFIC. (B)(6) 2016: (B)(6) MEDICAL CENTER. (B)(6), MD. H&P. CC: UMBILICUS WOUND; PATIENT STARTED WITH HERNIA REPAIR IN 2007, HAS HAD MULTIPLE ABDOMINAL SURGERIES SINCE W/DR. (B)(6) . HE REFERRED HER TO WOUND CLINIC WHEN SHE STARTED DRAINING AGAIN FOR PAST 2 YEARS. HPI: 51-YEAR-OLD FEMALE SEEN TODAY FOR UMBILICUS WOUND. HERNIA IN EPIGASTRIUM REPAIRED IN 20017 [SIC] WITH MESH. THE MESH ON HER CT DOES NOT LOOK INVOLVED, BUT COULD BE. THE MESH IS IN THE EPIGASTRIC AREA ABOVE THE UMBILICUS AND THERE IS A DEFECT AND POSSIBLE HERNIA JUST BELOW THIS AREA AT THE UMBILICUS. IT APPEARS THE MESH IS NOT INVOLVED WITH THIS ISSUE, BUT THERE REMAINS A POSSIBILITY THAT MESH COULD BE INVOLVED. WOUND ON UMBILICUS HAS BEEN PRESENT FOR APPROX. 1 YEAR AND 11 MONTHS. WOUND ARISES FROM AN UNKNOWN ORIGIN; MEASURES 0.4 CM X 0.4 CM X 0.1 CM. MODERATE AMOUNT OF SEROUS EXUDATE DRAINING FROM WOUND. WOUND BASE HYPER-GRANULATED, PAINFUL. WOUND BED HAS EXPOSED SUBCUTANEOUS TISSUE, SKIN AROUND WOUND TENDER TO PALPATION. PLAN IS TO APPLY AMD GAUZE DAILY FOR ONE MONTH. ROS: GI; NAUSEA. LYMPHATIC; HYPERCOAGULABLE STATE, H/O BLEEDING DISORDER, LYMPHEDEMA. EXAM: WT 240 LBS, BMI 39.9. ABDOMEN; SEROUS AND BLOODY DRAINAGE FROM UMBILICUS, GRANULATION TISSUE BOTTOM OF UMBILICUS. SKIN EXAM: ABDOMEN; DRAINAGE FROM DEPTHS OF UMBILICUS, TUFT OF GRANULATION TISSUE IN THE DEPTHS. NO OPEN WOUND NOTED TO FASCIA. PLAN: PRN SHARP DEBRIDEMENT. IMPRESSION: TUFT OF GRANULATION TISSUE; CAUTERIZED W/SILVER NITRATE, WILL SEE HOEW [SIC] RESOLVES PROBLEM. I DON¿T THINK THE MESH IS INVOLVED, BUT SHOULD HAVE AN INDEX OF SUSPICION. WILL FOLLOW TO SEE HOW THIS RESPONDS TO PRESENT MANAGEMENT. (B)(6) 2016: (B)(6) MEDICINE CENTER. (B)(6), MD. PROGRESS NOTE. WOUND MEASURES 0.1 CM X 0.1 CM X 0.1 CM; HAS DECREASED IN SIZE. MINIMUM AMOUNT OF SEROSANGUINEOUS EXUDATE. WOUND BASE HAS EXPOSED SUBCUTANEOUS. WOUND BASE GRANULATED, SKIN AROUND WOUND NORMAL. GOALS: AGGRESSIVE MANAGEMENT TO PROMOTE HEALING. IMPRESSION: REPORTS HER DRAINAGE HAS DECREASED. UMBILICUS PROBED; NO PURULENCE NOTED. VERY SMALL AREA OF GRANULATION CAUTERIZED W/SILVER NITRATE. UNSURE IF MESH FROM PREVIOUS HERNIA REPAIR INVOLVED AT THIS TIME. DRAINAGE IS IMPROVING; WILL CONTINUE CURRENT TREATMENT. (B)(6) 2016: THE WOUND CARE AND HYPERBARIC MEDICINE CENTER. NURSE NOTE. HERE FOR F/U; CONTINUES TO DRAIN MODERATE AMOUNT. SILVER NITRATE APPLIED. WOUND DRESSED. (B)(6) 2016: (B)(6) HOSPITAL LAB. (B)(6), MD. SURGICAL PATHOLOGY. ID: (B)(6). TYPE: TISSUE. SOURCE: SOFT TISSUE, DEBRIDEMENT. SPECIMEN: SOFT TISSUE, DEBRIDEMENT, ABDOMINAL WOUND. FINAL GROSS AND MICROSCOPIC DIAGNOSIS: SKIN AND SOFT TISSUE, PERIUMBILICAL WALL, EXCISION: LICHENOID CHRONIC INFLAMMATION IN THE SUPERFICIAL DERMIS. NO ACUTE INFLAMMATION. NO ATYPIA OR CARCINOMA IDENTIFIED. COMMENT: THE CLINICAL SUSPICION FOR OMPHALITIS IS NOTED. THE FINDINGS ARE CONSISTENT WITH THAT DIAGNOSIS. THERE IS NO EVIDENCE OF FISTULA. CLINICAL INFORMATION: ABDOMINAL WOUND. GROSS DESCRIPTION: RECEIVED IN A FORMALIN CONTAINER, LABELED WITH THE PATIENT¿S NAME, MEDICAL RECORD NUMBER, SPECIMEN SITE AND FURTHER DESIGNATED ¿ABDOMINAL WOUND¿ IS A FRAGMENT OF BROWN SKIN MEASURING 4.8 X 2.0 CM AND EXTENDS TO A DEPTH OF 4.3 CM. THE EPIDERMIS TRACKS TO THE DEEP EDGE OF THE SPECIMEN. THE FISTULA TRACT EXTENDS TO A DEPTH OF 4.0 CM. THE SURROUNDING SOFT TISSUES ARE GRAY-TAN AND APPEAR AS DENSE FIBROUS TISSUE. REPRESENTATIVE SECTIONS ARE SUBMITTED IN TWO CASSETTES. DIAGNOSES: WOUND ABSCESS. SPECIMENS COLLECTED: 1. SOURCE OF SPECIMEN: AP SPECIMEN. [MISSING RECORDS: RECORDS INCLUDING OP REPORT FOR REMOVAL OF NAVEL WERE NOT PROVIDED.] (B)(6) 2016: (B)(6) HOSPITAL. (B)(6), MD. ED NOTES. CC: POSTOP BLEEDING FROM HAVING NAVEL REMOVED ON MONDAY; BLEEDING AND DRAINAGE FROM AREA. HPI: PRESENTS WITH C/O DRAINAGE FROM SURGICAL INCISION. HAD SURGERY ABOUT 10 DAYS AGO; REMOVED NAVEL BECAUSE SHE WAS HAVING PERSISTENT HERNIAS AND INFECTIONS IN THAT AREA. DOING FINE UNTIL SHE HAD SOME FLUID LEAK OUT TODAY; NO TRAUMA, NO PRECIPITATING EVENTS. FLUID IS CLEAR AND REDNESS [SIC]. NO PUS, INCREASING PAIN, FEVERS, CHILLS, VOMITING OR RADIATION. DRAINAGE AMOUNT DESCRIBED AS SMALL MODERATE. MEDICATIONS: [INCLUDED] ASPIRIN. EXAM: GI; BOWEL SOUNDS NORMAL, SOFT, NO TENDERNESS OR MASSES. RECENT SURGICAL INCISION. STAPLES LOOK GOOD, NO DEHISCENCE. NO INDURATION, HEAT OR ERYTHEMA. VERY SMALL AMOUNT OF CLEAR REDDISH DRAINAGE; LOOKS LIKE A SEROMA. NO PURULENT DISCHARGE. IMPRESSION: EXAM MOST CONSISTENT W/ SMALL RECENTLY RUPTURED SEROMA. DO NOT SEE ANY EVIDENCE OF DEHISCENCE OR POSTSURGICAL INFECTION. SYMPTOMATIC AND SUPPORTIVE CARE; NO INTERVENTION NECESSARY. NO NEED FOR EMERGENT SURGICAL INTERVENTION OR CONSULTATION. CONTINUE CURRENT LOCAL WOUND CARE. F/U W/ DR. (B)(6) AS SCHEDULED. POSTSURGICAL SEROMA BY FAR MOST LIKELY ETIOLOGY.

Additional Manufacturer Narrative · 0

H6: ADDITIONAL HEALTH EFFECT- CLINICAL CODE. H6: UPDATED HEALTH EFFECT- CLINICAL CODE. H6: UPDATED INVESTIGATION FINDINGS. H6: UPDATED INVESTIGATION CONCLUSIONS D17: APPROPRIATE TERM/CODE NOT AVAILABLE. FOR "WITHDRAWN COMPLAINT". H6: HEALTH EFFECT IMPACT CODE: F26: NO HEALTH CONSEQUENCES OR IMPACT. H6: MEDICAL DEVICE COMPONENT: G04088: MEMBRANE. PREVIOUS PATIENT CODE (1994) WAS REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE PER GORE¿S INVESTIGATION. THIS CLAIM WAS WITHDRAWN, AND THE ALLEGED PRODUCT COMPLAINT IS NO LONGER BEING PURSUED AT THIS TIME. 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. MEDICAL RECORDS: ¿ THE KNOWN MEDICAL RECORDS SPAN (B)(6), 2005 THROUGH (B)(6), 2018 AND NOT ALL RECORDS RECEIVED IN THIS TIME SPAN ARE RELEVANT TO THE GORE® DUALMESH® BIOMATERIAL. ¿ RECORDS FROM (B)(6), 2008 THROUGH (B)(6), 2012; FROM (B)(6), 2014 THROUGH (B)(6), 2016 WERE NOT PROVIDED. PATIENT INFORMATION: MEDICAL HISTORY: ¿ ASTHMA WITH CHRONIC STEROID USE. ¿ CONGESTIVE HEART FAILURE. ¿ HYPERTENSION. ¿ OBESITY. (B)(6) 2004: 260 LBS.; BMI 43.4. (B)(6) 2007: 275 LBS.; BMI 45.8. (B)(6) 2010: 270 LBS.; BMI 44.9. (B)(6) 2012: 261 LBS.; BMI 43.43. (B)(6) 2013: 260 LBS.; BMI 43.4. (B)(6) 2014: 265 LBS.; BMI 44.1. ¿ ABDOMINAL WALL HERNIA. ¿ ABDOMINAL WOUND INFECTION; POSITIVE FOR STAPHYLOCOCCUS AUREUS ((B)(6) 2007). ¿ INFECTED SEROMA. PRIOR SURGICAL PROCEDURES: ¿ HERNIA REPAIR, TUBAL LIGATION [UNKNOWN DATE]. ¿ VAGINAL HYSTERECTOMY [UNKNOWN DATE]. ¿ (B)(6) 2007: REPAIR OF RECURRENT VENTRAL HERNIA, LYSIS OF ADHESIONS, REDUCTION OF PARTIAL SMALL BOWEL OBSTRUCTION, PARTIAL OMENECTOMY, REMOVAL OF SURGICAL MESH. IMPLANT PREOPERATIVE COMPLAINTS: ¿ (B)(6) 2008: CT ABDOMEN/PELVIS: ¿HX [HISTORY] OF RECENT HERNIA REPAIR BUT W/ PERSISTENT MIDLINE ABDOMINAL WALL HERNIA CONTAINING A LOOP OF SMALL BOWEL SHOWING NO ADDITIONAL COMPLICATION.¿ ¿ (B)(6) 2008: ¿RETURNS AFTER DR. (B)(6) PERFORMED RESECTION OF MESH AND REPAIR OF A MULTIPLY RECURRENT INCISIONAL HERNIA ON (B)(6) 2007. AT THAT TIME, HAD SMALL PARTIAL BOWEL RECONSTRUCTION, PARTIAL OMENTECTOMY AS WELL. PRIMARILY REPAIRED THE HERNIA W/ PDS. HERNIA HAS RECURRED, WAS RECENTLY IN ED WITH CT SCAN THAT DEMONSTRATED A LOOP OF BOWEL WITHIN THE HERNIA; CURRENTLY NOT OBSTRUCTED. C/O [COMPLAINS OF] MINIMAL TENDERNESS AROUND HERNIA ITSELF.¿ ¿GOING TO BE DIFFICULT REPAIR. SHE IS VERY OBESE, AND HER RISKS FOR RECURRENCE OR WOUND COMPLICATIONS ARE SIGNIFICANT. WHAT SHE NEEDS IS PLACEMENT OF GORE-TEX DUALMESH IN A RETRO-FASCIAL LOCATION, AND THIS WILL HAVE TO BE A LARGE PIECE OF GORE-TEX DUALMESH. I HAVE COUNSELED HER ON NEED FOR WEIGHT LOSS.¿ IMPLANT PROCEDURE: REPAIR OF INCARCERATED INCISIONAL HERNIAS WITH ¿GORE-TEX DUALMESH.¿ IMPLANT: GORE® DUALMESH® BIOMATERIAL (03158621/1DLMC03) 10CM X 15CM, OVAL. IMPLANT DATE: (B)(6), 2008 [HOSPITALIZED (B)(6), 2008]. ¿ DESCRIPTION OF HERNIA BEING TREATED: ¿THE UPPER ABDOMINAL FASCIA WAS DISSECTED FIRST WHERE THERE WERE NO PRIOR INCISIONS. THE FASCIA WAS VERY THIN HERE, BUT OTHERWISE HEALTHY. THE FASCIA WAS DIVIDED AND EXPOSURE WAS GAINED INTO THE PERITONEAL SPACE. I THEN PROCEEDED TO DISSECT THE HERNIA SAC OUT AND REDUCE IT BACK INTO THE ABDOMEN. IT WAS INCARCERATED. SEVERAL SMALL DEFECTS WERE JOINED TO MAKE A LARGER DEFECT BY DIVIDING THE BANDS AND SEPARATING THEM. SHARP DISSECTION ONLY WAS USED TO MOBILIZE THE SMALL BOWEL AND OMENTUM BACK INTO THE ABDOMEN AND AFTER DISSECTING OUT THE ANTERIOR ABDOMINAL WALL IN THIS AREA, CIRCUMFERENTIALLY, PROXIMALLY 4 CM BEYOND THE HEALTHY FASCIAL EDGE.¿ ¿ IMPLANT SIZE AND FIXATION: ¿I THEN SEWED IN A PIECE OF GORE-TEX DUALMESH WITH INTERRUPTED 0 ETHIBOND TRANSFACIAL [SIC] SUTURES. WITH THE SMOOTH SIDE DOWN, TOWARD THE BOWEL. A 10 X 15 CM PIECE OF GORE-TEX DUALMESH WAS USED.¿ ¿ POST-OPERATIVE PERIOD: [ONE DAY]. (B)(6) 2008: DISCHARGE SUMMARY: ¿ADMITTED (B)(6) 2008 AFTER VENTRAL HERNIA REPAIR W/MESH. DID WONDERFUL OVERNIGHT; REMAINED AFEBRILE, WAS TOLERATING A REGULAR PO DIET, ADEQUATE PAIN CONTROL, AMBULATING WELL. J-VAC DRAIN PULLED PRIOR TO DISCHARGE.¿ RELEVANT MEDICAL INFORMATION: ¿ (B)(6) 2008: ¿SHARP PAIN JUST UNDER SCAR FROM RECENT INCISION HERNIA REPAIR. OUT OF PAIN MEDICINE, DENIES FEVER, HAS NAUSEA NO VOMITING OR DIARRHEA.¿ ¿ABDOMEN; OBESE, TENDERNESS UNDERNEATH SCAR FROM RECENT SURGERY, NO SIGN OF DEHISCENCE OR INFECTION. CT ABD/PELVIS NEGATIVE. IMPRESSION: PROBABLY STRESSED SCAR TISSUE.¿ ¿ (B)(6) 2008: CT ABDOMEN/PELVIS: ¿PRIOR ANTERIOR ABDOMINAL WALL HERNIA REPAIR WITHOUT COMPLICATION OR RECURRENCE. OTHERWISE UNREMARKABLE CT SCAN.¿ ¿ (B)(6) 2012: ¿CHRONIC BACK PAIN. ABDOMINAL PAIN. EXPECTANT TREATMENT WITH ANTACID.¿ ¿ (B)(6) 2014: ¿C/O RATHER DIFFUSE ABDOMINAL PAIN. NO FEVER. CANNOT LOCALIZE THE PAIN ALTHOUGH IT SEEMS MORE INTENSE ACROSS UPPER ABDOMEN.¿ ¿ (B)(6) 2014: ¿C/O LEFT HIP PAIN, MID ABDOMINAL PAIN. NO FEVER, VOMITING OR DIARRHEA; HAS HAD NAUSEA. HAS BAD HIP PROBLEM; WHEN SHE ¿FAVORS THAT HIP, IT CAUSES HER STOMACH TO HURT, SHE¿S HAD MULTIPLE HERNIA SURGERIES ON HER STOMACH¿.¿ ¿ (B)(6) 2016: ¿PRESENTS FOR REPORTED PERIUMBILICAL AREA ABDOMINAL PAIN ALONG W/ REPORTED DRAINAGE AROUND BELLYBUTTON. SYMPTOMS PRESENT PAST 3-4 YEARS SINCE PRIOR SURGERY. SLOWLY WORSENING OVER TIME; HAS NOT FOLLOWED UP RECENTLY W/ SURGEON. NO ACUTE TRAUMA, FEVER, CHILLS, NAUSEA, VOMITING OR DIARRHEA. NO BLEEDING FROM AREA.¿ ¿VERY SMALL AMOUNT OF DRAINAGE FROM UMBILICUS; NO ACTIVE BLEEDING. NO FLUCTUANCE OR ERYTHEMA NOTED AROUND ABDOMEN.¿ ¿ (B)(6) 2016: CT ABDOMEN/PELVIS: ¿CAUDAL TO THE NASH [SIC], IS AN UMBILICAL HERNIA THAT CONTAINS SOFT TISSUE DENSITY NOT REPRESENTING FAT NOR OPACIFIED SMALL BOWEL. OTHERWISE NONSPECIFIC.¿ ¿ (B)(6) 2016: ¿51-YEAR-OLD FEMALE SEEN TODAY FOR UMBILICUS WOUND. HERNIA IN EPIGASTRIUM REPAIRED IN 2017 [SIC] WITH MESH. THE MESH ON HER CT DOES NOT LOOK INVOLVED, BUT COULD BE. THE MESH IS IN THE EPIGASTRIC AREA ABOVE THE UMBILICUS AND THERE IS A DEFECT AND POSSIBLE HERNIA JUST BELOW THIS AREA AT THE UMBILICUS. IT APPEARS THE MESH IS NOT INVOLVED WITH THIS ISSUE, BUT THERE REMAINS A POSSIBILITY THAT MESH COULD BE INVOLVED. WOUND ON UMBILICUS HAS BEEN PRESENT FOR APPROX. 1 YEAR AND 11 MONTHS. WOUND ARISES FROM AN UNKNOWN ORIGIN; MEASURES 0.4 CM X 0.4 CM X 0.1 CM. MODERATE AMOUNT OF SEROUS EXUDATE DRAINING FROM WOUND. WOUND BASE HYPER-GRANULATED, PAINFUL. WOUND BED HAS EXPOSED SUBCUTANEOUS TISSUE, SKIN AROUND WOUND TENDER TO PALPATION.¿ ¿ (B)(6) 2016: ¿VERY SMALL AREA OF GRANULATION CAUTERIZED W/SILVER NITRATE. UNSURE IF MESH FROM PREVIOUS HERNIA REPAIR INVOLVED AT THIS TIME. DRAINAGE IS IMPROVING; WILL CONTINUE CURRENT TREATMENT.¿ ¿ (B)(6) 2016: SURGICAL PATHOLOGY: ¿THE CLINICAL SUSPICION FOR OMPHALITIS IS NOTED. THE FINDINGS ARE CONSISTENT WITH THAT DIAGNOSIS. THERE IS NO EVIDENCE OF FISTULA.¿ ¿ (B)(6) 2016: ¿PRESENTS WITH C/O DRAINAGE FROM SURGICAL INCISION. HAD SURGERY ABOUT 10 DAYS AGO; REMOVED NAVEL BECAUSE SHE WAS HAVING PERSISTENT HERNIAS AND INFECTIONS IN THAT AREA [OPERATIVE REPORT FOR THIS PROCEDURE WAS NOT PROVIDED]. DOING FINE UNTIL SHE HAD SOME FLUID LEAK OUT TODAY; NO TRAUMA, NO PRECIPITATING EVENTS. FLUID IS CLEAR AND REDNESS [SIC]. NO PUS, INCREASING PAIN, FEVERS, CHILLS, VOMITING OR RADIATION. DRAINAGE AMOUNT DESCRIBED AS SMALL MODERATE.¿ ¿EXAM MOST CONSISTENT W/ SMALL RECENTLY RUPTURED SEROMA. DO NOT SEE ANY EVIDENCE OF DEHISCENCE OR POSTSURGICAL INFECTION. SYMPTOMATIC AND SUPPORTIVE CARE; NO INTERVENTION NECESSARY. NO NEED FOR EMERGENT SURGICAL INTERVENTION OR CONSULTATION.¿ ¿ (B)(6) 2017: ¿APPEARS TO BE EITHER WOUND SEPARATION OR PERHAPS SOME CHRONICALLY DRAINING TYPE WOUND, PERHAPS A FISTULA AT THIS POINT. WILL PLACE ON ANTIBIOTICS; DOES NOT NEED TO BE ADMITTED. REFER BACK TO SURGEON FOR EVALUATION.¿ ¿ (B)(6) 2017: ABDOMINAL WOUND CULTURE: ¿1+ METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS.¿ EXPLANT PREOPERATIVE COMPLAINTS: ¿ (B)(6) 2017: ¿WOUND INFECTION TO AREA WHERE SHE HAD NAVEL SURGERY IN (B)(6). REPORTS PAIN TO AREA; HAS BEEN OCCURRING INTERMITTENTLY SINCE THEN.¿ ¿URGENT EVALUATION OF PATIENT W/RECURRENT PERIUMBILICAL DRAINAGE PROCEDURE PERFORMED SEVERAL MONTHS AGO. DIFFERENTIAL DIAGNOSIS WOULD INCLUDE ABDOMINAL WALL ABSCESS OF VARYING DEPTHS. UMBILICUS ABSCESS, SEROMA, FISTULA, OTHER ETIOLOGIES CONSIDERED.¿ ¿ (B)(6) 2017: ABDOMINAL WOUND CULTURE: ¿1+ STAPHYLOCOCCUS AUREUS, 1+ DIPTHEROIDS.¿ ¿ (B)(6) 2017: CT ABDOMEN/PELVIS: ¿CHANGES OF ANTERIOR ABDOMINAL WALL REPAIR. JUST CAUDAL TO MESH THERE IS A 2.3 CM LOW-DENSITY UMBILICAL HERNIA CONTAINING LOW DENSITY MATERIAL. NO INTRA-ABDOMINAL CONNECTION CONFIRMED. SOFT TISSUE DENSITY INCREASED IN SIZE SINCE PRIOR STUDY.¿ EXPLANT PROCEDURE: EXPLANTATION OF ¿GORE-TEX DUALMESH¿. ABDOMINAL WALL RECONSTRUCTION USING SURGIMEND 3MM MESH. LYSIS OF ADHESIONS. EXPLANT DATE: (B)(6), 2017. ¿ ¿THE PATIENT HAD A CHRONIC DRAINING SINUS ALL THE WAY DOWN TO A WAD OF SUTURE AND CHRONICALLY INFLAMED FASCIA. JUST BENEATH THIS WAS A FLUID COLLECTION CONSISTING OF CLOUDY PURULENT APPEARING FLUID. THE GORE-TEX DUALMESH HOWEVER WAS FAIRLY INCORPORATED.¿ ¿THE PATIENT HAD MULTIPLE PROCEDURES TO TRY TO REMEDY A CHRONIC DRAINING SINUS JUST OVERLYING SOME GORE-TEX DUALMESH THAT WAS PLACED YEARS AGO. DESPITE MULTIPLE DEBRIDEMENTS AND EXCISIONS AND WASHOUTS AND ANTIBIOTICS THIS DRAINING SINUS HAS NOT HEALED AND A COMPUTED TOMOGRAPHY SCAN SUGGESTS A FLUID COLLECTION ADJACENT TO SOME GORE-TEX DUALMESH. I HAVE RECOMMENDED EXPLAINED [SIC] IN THE MESH AS A DEFINITIVE TREATMENT TO THIS CHRONIC DRAINING SINUS TRACT.¿ ¿ ¿A SIX-INCH ELLIPTICAL INCISION WAS MADE WITH THE KNIFE AND CARRIED DOWN THROUGH THE SUBCUTANEOUS TISSUE WITH BOVIE CAUTERY. THE RESECTION EXTENDED DOWN TO THE FASCIA WHERE UPON A GROUPING OF SUTURES INVOLVED IN AN INFLAMMATORY PROCESS WITH SOME SEROPURULENT FLUID WAS ENCOUNTERED. AT THAT POINT I INCISED THE MESH IN THE MIDLINE AND CAREFULLY DISSECTED OFF SOME SMALL BOWEL WHICH WAS CLOSELY ADHERENT TO THE MESH BUT DID NOT PRODUCE EVIDENCE OF FISTULA. AFTER DISSECTING ALL OF THE SMALL BOWEL OFF OF THE GORE-TEX DUALMESH THE MESH WAS EXPLANTED USING THE CAUTERY AS IT WAS STILL FAIRLY INCORPORATED. THE ENTIRE MESH WAS EXPLANTED AND THE SMALL BOWEL WAS CLOSELY INSPECTED. ONE AREA WHICH WAS ESPECIALLY CLOSELY ADHERENT TO THE MESH WAS LEMBERTED WITH INTERRUPTED 3-0 VICRYL BUT THE REMAINING BOWEL LOOKED GOOD. A FAIRLY SIGNIFICANT LYSIS OF ADHESIONS HAD TO BE PERFORMED TO BOTH REFLECT THE OMENTUM AND SMALL BOWEL OFF OF THE GORE-TEX DUALMESH BUT ALSO TO DISSECTED [SIC]SMALL BOWEL AWAY FROM OTHER BOWEL LOOPS IN ORDER TO CLOSELY INSPECTED [SIC]. NEXT AN INTRAPERITONEAL PIECE OF 3 MM SURGIMEND MESH WAS SEWN INTO PLACE WITH INTERRUPTED #1 PDS TRANS-FASCIAL SUTURES.¿ ¿ RECORDS INDICATE A NON-GORE DEVICE WAS IMPLANTED DURING THE (B)(6) 2017 PROCEDURE. RELEVANT MEDICAL INFORMATION: ¿ (B)(6) 2017: WOUND CULTURE: ¿NO ORGANISMS SEEN.¿ ¿ (B)(6) 2017: ¿NO COMPLAINTS. WALKING THE HALLS, TOLERATING CLEARS. AFVSS [AFEBRILE, VITAL SIGNS STABLE]. ABD [ABDOMEN] OK. DRAIN SEROSANGUINOUS. WILL ADVANCE DIET, IF CONTINUES TO DO WELL PLAN FOR DC [DISCHARGE] TOMORROW.¿ ¿ (B)(6) 2017: DISCHARGE SUMMARY: ¿UNDERWENT EXPLANTATION OF MESH THROUGH A MIDLINE INCISION. THE FASCIA DEFECT WAS REPAIRED WITH BIOLOGIC MESH. DID WELL AND WAS DISCHARGED HOME IN GOOD CONDITION.¿ CONCLUSION: IT SHOULD BE NOTED THAT THE GORE® DUALMESH® 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® 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.¿ THE GORE® DUALMESH® BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: ¿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 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 MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, RECURRENCE, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, PAIN, PARESTHESIA, PERFORATION, REVISION / RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, WOUND COMPLICATIONS AND WOUND DEHISCENCE. 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.

Additional Manufacturer Narrative · 1

(B)(6). IT SHOULD BE NOTED THAT THE GORE® DUALMESH® 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.¿

Description of Event or Problem · 1

IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL, ADDITIONAL SURGERY, PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
487581	GORE DUALMESH BIOMATERIAL	MESH, SURGICAL, POLYMERIC	FTL	W.L. GORE & ASSOCIATES	1DLMC03	03158621	00733132600960

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR		Hospitalization\| R