PHASIX MESH

Description of Event or Problem

PER INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH VENTRAL ABDOMINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OP NOTES, "A LARGE HERNIA SAC WAS IDENTIFIED AND WAS EXCISED. A MEDIUM SIZED COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED TO THE ABDOMINAL CAVITY USING SUTURES." (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA WITH STRANGULATED SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT REPAIR WITH REMOVAL OF OLD MESH (DEVICE 1), LYSIS OF ADHESIONS AND RESECTION OF THE SMALL BOWEL. PER OP NOTES, "SMALL BOWEL WAS DENSELY ADHERENT TO THE OLD MESH. LYSIS OF ADHESIONS WAS PERFORMED, THE OLD MESH (DEVICE 1) WAS REMOVED." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LARGE INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, "A VERTICAL INCISION WAS MADE IN THE ABDOMEN, A PHASIX MESH (DEVICE 2) WAS PLACED USING SUTURES." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WALL SEROMA THEREBY UNDERWENT INCISION AND DRAINAGE, DEBRIDEMENT OF THE ABDOMINAL WALL AND MESH REMOVAL (DEVICE 2). PER OP NOTES, "ELLIPTICAL INCISION WAS MADE IN THE ABDOMEN, THE MESH (DEVICE 2) WAS REMOVED."

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-2014) IS CONSIDERED TO BE A BEST ESTIMATE. THIS MDR REPRESENTS THE PHASIX MESH (DEVICE 2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE COMPOSIX KUGEL 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.