PHASIX MESH

Description of Event or Problem

PER INFORMATION PROVIDED: ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿VENTRAL HERNIA WAS IDENTIFIED. A VENTRALEX MESH (DEVICE 1) WAS PLACED INFERIOR TO FASCIAL EDGES AND SECURED ON ALL SIDES USING SUTURES.¿ ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS, MESH EROSION, BOWEL PERFORATION THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, ¿ABSCESS WAS DRAINED. THERE WAS A PERFORATION OF THE SMALL BOWEL WITH MESH (DEVICE 1) ERODING INTO THE SMALL BOWEL. ADHESIONS WERE LYSED. LOOPS WHICH WERE INVOLVED WITH MESH EROSION WAS RESECTED. ONLAY PHASIX MESH (DEVICE 2) WAS PLACED AND SECURED USING SUTURE.¿ ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH NECROTIC WOUND THEREBY UNDERWENT DEBRIDEMENT OF NECROTIC WOUND. ON (B)(6) 2021 ¿ PATIENT WAS DIAGNOSED WITH NONHEALING SURGICAL WOUND THEREBY UNDERWENT SCAR REVISION AND REMOVAL OF MESH (DEVICE 2). PER OP NOTES, ¿INCISION WAS MADE TO REMOVE ENTIRE AREA AND TO REDUCE PUCKERING INCORPORATING WOUND. THERE WAS STILL SOME PHASIX MESH (DEVICE 2) WAS CURETTED OFF.¿

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-DEC-2019) IS CONSIDERED TO BE A BEST ESTIMATE. THIS EMDR REPRESENTS THE BD PHASIX MESH (DEVICE 2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE BD MESH -VENTRALEX MESH (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.