PHASIX MESH

Description of Event or Problem

PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OP NOTES, "THE MIDLINE INCISION WAS MADE, A VENTRALEX ST MESH (DEVICE 1) WAS PLACED USING PROLENE SUTURES." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH EXPLANT OF OLD MESH (DEVICE 1) AND IMPLANT OF PHASIX MESH (DEVICE 2). PER OP NOTES, "SCAR TISSUE WAS EXCISED, THE MESH (DEVICE 1) WAS REMOVED. TOOK DOWN ADHESIONS BETWEEN THE ANTERIOR ABDOMINAL WALL. A PHASIX MESH (DEVICE 2) WAS PLACED TO THE SYMPHYSIS PUBIS." (B)(6)2015 - PATIENT WAS DIAGNOSED WITH WOUND INFECTION THEREBY UNDERWENT INCISION AND DRAINAGE OF INFECTED ABDOMINAL WOUND. PER OP NOTES, "THE INFERIOR PORTION OF THIS HAD EXPOSED PHASIX MESH (DEVICE 2) THAT SEEMED TO BE WELL INCORPORATED."

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-APR-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 VENTRALEX ST 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.