PHASIX MESH

Description of Event or Problem

PER INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE PERITONEAL CAVITY. HERNIA SAC WAS DISSECTED OUT. A SEPRAMESH IP (DEVICE 1) WAS PLACED INTO THE ABDOMINAL CAVITY AND SECURE IT WITH SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA, PAIN, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF SEPRAMESH IP (DEVICE 1) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE RIGHT LOWER ABDOMEN. HERNIA SAC WAS DISSECTED OUT. THERE WAS DENSE ADHESION INTO THE ABDOMEN, WHICH WAS REMOVED ENTIRELY. PREVIOUSLY PLACED SEPRAMESH IP (DEVICE 1) WAS CRUMPLED AND THAT WAS REMOVED ENTIRELY. A SYNTHETIC MESH WAS PLACED INTO THE DEFECT AND SUTURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA, ADHESION, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 2) AND PHASIX FLAT MESH (DEVICE 3). PER OPERATIVE NOTES, ¿A LOWER ABDOMEN VENTRAL HERNIA SAC WAS IDENTIFIED. HERNIA SAC WAS EXCISED FROM ABDOMEN. LYSIS OF ADHESION WAS PERFORMED. BARD FLAT MESH (DEVICE 2) AND PHASIX FLAT MESH (DEVICE 3) WAS PLACED INTO THE ABDOMINAL WALL AND SECURE IT WITH SUTURES.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WOUND DEHISCENCE, NECROSIS THEREBY UNDERWENT REPAIR WITH EXCISIONAL DEBRIDEMENT OF LOWER ABDOMINAL WOUND. PER OPERATIVE NOTES, ¿WOUND DEHISCENCE WAS DEVELOPED WHICH WAS TREATED WITH REVISION AND CLOSER. ALL THE NECROTIC TISSUE, INCLUDING LARGE AMOUNT OF NECROTIC NONHEALING FAT WERE EXCISED.¿

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-JUN-2016) IS CONSIDERED TO BE A BEST ESTIMATE. THIS EMDR REPRESENTS THE PHASIX FLAT MESH (DEVICE 3). ADDITIONAL SUPPLEMENTAL EMDR AND EMDR WERE SUBMITTED TO REPRESENT THE SEPRAMESH IP (DEVICE 1) AND BARD FLAT MESH (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.