PHASIX MESH

Description of Event or Problem

PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 1). PER OP NOTES, "INCISION WAS MADE AROUND THE UMBILICAL REGION. A PERFIX PLUG AND PATCH (DEVICE 1) WAS PLACED INTO THE DEFECT USING PROLENE SUTURES." (B)(6) 2012 - PATIENT HAD PARTIAL SMALL BOWEL OBSTRUCTION AND ABDOMINAL PAIN. (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA AND INFECTED ABDOMINAL WALL MESH THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, "EROSION OF SMALL BOWEL TO MESH AT THE UMBILICUS WITH ENTEROCUTANEOUS FISTULA. LOOP OF BOWEL STUCK UP TO THE BACKSIDE OF IT THAT WAS FISTULIZED TO THE MESH AND THE MESH (DEVICE 1) WAS REMOVED. A PHASIX MESH (DEVICE 2) WAS PLACED INTO THE WOUND." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WOUND INFECTION THEREBY UNDERWENT INCISION AND DRAINAGE OF ABDOMINAL WOUND. PER OP NOTES, "PATIENT HAD A HEMATOMA AND WAS EVACUATED. AT THE BASE OF THE WOUND WAS A PIECE OF MESH (DEVICE 2) THAT WAS SUTURED TO THE PATIENT ABDOMEN."

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. NOTE, THE MANUFACTURING DATE (15-NOV-2016) IS CONSIDERED TO BE A BEST ESTIMATE. THIS EMDR REPRESENTS THE PHASIX MESH (DEVICE 2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE BARD PERFIX PLUG (DEVICE 1). 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.