PHASIX MESH

Additional Manufacturer Narrative

ROOT CAUSE IS INCONCLUSIVE; NO CONCLUSION CAN BE MADE AS TO THE EXTENT TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE. THIS EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL PHASIX MESH (DEVICE #3). ADDITIONAL SUPPLEMENTAL EMDR REPRESENTS THE BARD/DAVOL VENTRIO MESH (DEVICE #1) AND VENTRIO ST (DEVICE #2). NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT 2 INCISIONAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. A VENTRIO MESH (DEVICE #1) WAS PLACED JUST ABOVE THE UMBILICUS AND SECURE IT WITH SUTURE.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, ADHESION, SCAR TISSUE THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF THE BARD VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. THE OLD MESH WAS FOLDED. BARD VENTRIO MESH (DEVICE #1) WAS PLACED AND SUTURED. VENTRIO ST MESH (DEVICE #2) WAS ANCHORED AT THE SUPERIOR AND LATERAL OLD VENTRIO MESH (DEVICE #1) TO PROVIDE POSITIONAL STABILITY.¿ ON (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH ACUTE RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REINFORCEMENT WITH BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿OLD MESH HAD CRUMPLES AND ROTATED. ONE BIOLOGICAL MESH WAS PLACED TO ABDOMEN AREA AND SECURE IT WITH SUTURE.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA, ADHESION, 5 INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH LYSIS OF ADHESIONS, VENTRAL HERNIA REPAIR, SMALL BOWEL RESECTION AND ANASTOMOSIS. ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WALL MESH WITH SUBCUTANEOUS FISTULA, ADHESION, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRIO MESH (DEVICE #1) AND VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. INTRA-ABDOMINAL WALL OMENTAL AND BOWEL ADHESIONS WERE TAKEN DOWN. VENTRIO MESH (DEVICE #1) AND VENTRIO ST MESH (DEVICE #2) WAS REMOVED FROM ABDOMINAL AREA. WOUND WAS COVERED WITH VAC PLACEMENT. HERNIA DEFECT WAS CLOSED WITH SUTURES.¿ ON (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH LARGE VENTRAL INCISIONAL HERNIA; ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PHASIX MESH (DEVICE #3). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED OUT. SMALL BOWELS AND ADHESIONS WERE TAKEN DOWN. ONE PHASIX MESH (DEVICE #3) WAS PLACED AND SECURE IT WITH SUTURE.¿ ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH CHRONIC ABDOMINAL WALL SINUS THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF PHASIX MESH (DEVICE #3). PER OPERATIVE NOTES, ¿THERE WAS SMALL AMOUNT OF PURULENT AROUND THE OLD PHASIX MESH (DEVICE #3). OLD PHASIX MESH (DEVICE #3) WAS REMOVED. THE WOUND WAS IRRIGATED. FASCIA WAS CLOSED WITH SUTURES.¿ ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA; ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE #4). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED OUT. ALL ADHESIONS WERE REMOVED. A VENTRALIGHT ST MESH (DEVICE #4) WAS PLACED AND SECURE IT WITH SUTURE.¿