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Patient 1
A CASE WAS RECEIVED FROM THE FDA (REPORT NUMBER: MW5070605). IT REPORTED THE FOLLOWING: SURGERY TO INCLUDE SERI MESH SCAFFOLD (ALLERGAN MANUFACTURED) SINCE NOW THEY HAVE SOLD TO SOFREGEN MEDICAL, SINCE INITIAL INSTALL ON (B)(6) 2015-LEADING TO INFECTION WHICH HAS RESULTED IN MULTIPLE SURGERIES TO REMOVE, EFFORTS TO CORRECT DAMAGING EFFECTS FROM THE MEDICAL DEVICE AND LONG TERM ANTIBIOTICS. ON (B)(6) 2017, THE REPORTER WAS CALLED AND A MESSAGE WAS LEFT REQUESTING ADDITIONAL INFORMATION.ON (B)(6) 2017, THE REPORTER CALLED AND STATED SHE HAD THICK CASE FILE REGARDING THE ISSUES SHE HAS EXPERIENCED. SHE IS WILLING TO SHARE THE INFORMATION WITH SOFREGEN AND WILL EMAIL THE INFORMATION SHE IS WILLING TO SHARE. ON (B)(6) 2017 SHE SHARED THE FOLLOWING INFORMATION.PROCEDURE DATE: (B)(6) 2015: OPERATIONS PERFORMED: ABDOMINAL WALL REINFORCEMENT WITH 10 X 15 CM BIOLOGICAL MESH, BILATERAL IMPLANTABLE DOPPLER PLACEMENT, AND MULTILEVEL INTERCOSTAL NERVE BLOCKADE WITH 20 MG OF LIPOSOMAL BUPIVACAINE OF CHEST AND ABDOMEN FOR POSTOPERATIVE ANALGESIA.THE FINDINGS FROM THESE PROCEDURES AS THEY PERTAIN TO SERI ARE AS FOLLOWS: ATTENTION WAS THEN TURNED TO CLOSING THE ABDOMEN. THE ABDOMINAL FASCIA WAS CLOSED IN A LAYERED FASHION USING A ETHIBOND SUTURE. ONE PIECE OF 10 X25 CM BIOLOGICAL MESH WAS THEN OVERLAID OVER THE FASCIAL REPAIR AND INSET USING 0 ETHIBOND SUTURES. THE PATIENT WAS THEN FLEXED IN A BEACH-CHAIR POSITION. THE SUPERIOR ABDOMINAL FLAP WAS THEN TAILOR TACKED TO THE LOWER ABDOMINAL FLAP AND THE UMBILICUS WAS INSET THROUGH A SEPARATE CHEVRON INCISION USING 4-6 MONOCRYL AND 5-0 PROLENE SUTURES. THE UMBILICUS WAS PINK AND VIABLE AT THE COMPLETION OF THE INSET. THE ABDOMEN WAS THEN CLOSED IN A LAYERED FASHION USING #2 QUILL PDO SUTURES TO CLOSE THE SCARPA FASCIA, FOLLOWED BY 3-0 PDS V-LOC SUTURES IN THE SUBTICULAR PLANE. TWO 19-FRENCH ROUND DRAINS WERE PLACED IN THE ABDOMEN THROUGH SEPARATE STAB INCISIONS AND ANCHORED TO THE SKIN USING 2-0 PROLENE SUTURES. ON (B)(6) 2015, THE PATIENT HAD ADDITIONAL PROCEDURES PERFORMED DUE TO COMPLICATIONS OF THE ABDOMEN WITH AN INDOLENT INFECTION ATTRIBUTED TO A SPITTING SUTURE OF THE TRANSVERSE LOWER ABDOMINAL INCISION AS WELL AS AT THE UMBILICUS. THE PROCEDURES PERFORMED INCLUDED THE FOLLOWING THAT PERTAINED TO THE SERI SURGICAL MESH: PROCEDURE-ABDOMINAL EXPLORATION WITH INCISION AND DRAINAGE AND DEBRIDEMENT OF BIOLOGIC MESH WITH COMPLEX CLOSURE OF ABDOMEN. TOTAL MEASUREMENT 30 CM X20 CM. THE FOLLOWING ARE NOTES FROM THE PROCEDURE THAT PERTAIN TO SERI. PROCEDURE IN DETAIL-ATTENTION WAS THEN TAKEN TO THE LOWER ABDOMINAL INFECTION. THE TEGADERM AND GAUZE WERE REMOVED. THERE WAS SOME PURULENT INFECTION IDENTIFIED FROM THE UMBILICUS AS WELL AS FROM THE TRANSVERSE ABDOMINAL INCISION APPROXIMATELY 1 CM IN DIAMETER IN BOTH SITES. THESE AREAS WERE MARKED WITH INDELIBLE MARKER. THE AREA WAS RE-PREPPED AGAIN USING BETADINE. THE AREA WAS EXCISED FULL THICKNESS, BOTH THE UMBILICUS AND TRANSVERSE ABDOMINAL INCISION. UPON OPENING THE INCISION THERE WAS PURULENT DAMAGE FROM THE WOUND WHICH WAS THEN CULTURED AND SENT OFF THE FIELD. IT WAS IDENTIFIED THAT THE WOUND INFECTION TRACKING MORE LATERALLY, SO THE REMAINING MID LOWER ABDOMINAL INCISION WAS THEN OPENED AND THE HEALING TISSUE AS WAS EXCISED FULL THICKNESS AS WELL AS THE SKIN AND SUBCUTANEOUS TISSUE DOWN TO THE ABDOMINAL WALL FASCIA. THE SERI SCAFFOLD BIOLOGIC MESH WAS IDENTIFIED NOT INCORPORATED IN THE UNDERLYING ABDOMINAL FASCIA AND WAS SHARPLY DEBRIDED. THERE WAS GROSS INFLAMMATORY TISSUE AN INFECTION IDENTIFIED IN THE LOWER ABDOMEN. THE AREA WAS COPIOUSLY IRRIGATED AND WASHED WITH BETADINE SOLUTION AS WELL AS NORMAL SALINE. THE SINUS TRACK WAS THEN IDENTIFIED TO TRACK TO THE UMBILICUS WHICH WAS THEN FURTHER EXPOSED WITH EXCISING MORE OF THE INFLAMMATORY INFECTED TISSUE AND DEBRIDING MORE OF THE BIOLOGIC SERI SCAFFOLD MESH. A TOTAL OF APPROXIMATELY 12 X12 CM OF THE SCAFFOLD MESH WAS THEN DEBRIDED FROM THE ABDOMEN LATERALLY AND SUPERIORLY. THE MAJORITY OF THE MESH HAD BEEN INCORPORATED WITH HEALING GRANULATION TISSUE AND UNABLE TO BE DEBRIDED. AFTER COPIOUS IRRIGATION AND WASHING OUT, A 19-FRENCH ROUND DRAIN WAS THEN PLACED THROUGH SEPARATE STAB INCISIONS ON THE LEFT SIDE FROM THE AREA OF FAT HARVEST AND ANCHORED TO THE SKIN USING 4-0 NYLON AS WELL AS 2-0 PROLENE AND SET TO A CLOSE SUCTION DRAIN. THE ABDOMINAL INCISION WAS THEN CLOSED IN A LAYERED FASHION, FIRST THE SCARP FASCIA USING 2-0 VICRYL SUTURE, FOLLOWED BY 3-0 VICRYL SUTURE THROUGH THE DEEP DERMAL CLOSURE, FOLLOWED BY 4-0 NYLON IN A RUNNING CONTINUOUS FASHION OVER THE TRANSVERSE INCISION. THE LOWER ABDOMEN HAD BEEN WIDELY UNDERMINED IN ORDER FOR DEBRIDEMENT OF ALL THE INFECTED MESH AS WELL AS INCISION AND DRAINAGE OF THE ENTIRE INFECTION, TOTALING 30 X 30 CM2. A SMALL VERTICAL INCISION ADJACENT TO THE UMBILICUS WAS ALSO CLOSED IN LAYERED FASHION USING 2-0 AND 3-0 VICRYL SUTURE FOLLOWED BY INTERRUPTED 4-0 NYLON. THE AREA WAS THEN COVERED WITH STERI-STRIPS AND A STERILE DRESSING. THE P...