PHASIX MESH

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-JUL-2018) IS CONSIDERED TO BE A BEST ESTIMATE. 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.

Description of Event or Problem

PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH EPIGASTRIC AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1) AND VENTRALEX MESH (DEVICE 2). PER OP NOTES, "PREVIOUS INCISION OVER THE PATIENT'S EPIGASTRIC HERNIA, A COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED IN THE ABDOMINAL CAVITY USING PROLENE SUTURES. ATTENTION WAS THEN TURNED TO THE UMBILICUS WHERE A SUPRAUMBILICAL INCISION WAS MADE, A VENTRALEX MESH (DEVICE 2) WAS PLACED IN THE DEFECT USING PROLENE SUTURES." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL UMBILICAL HERNIA THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE 1 AND 2) AND IMPLANT OF PHASIX MESH (DEVICE 3). PER OP NOTES, "PATIENT'S PREVIOUS MIDLINE INCISION WAS EXTENDING TO THE LEVEL OF THE UMBILICUS. THERE WAS A DEFECT PRESENT IN THE FASCIA AS WELL AS MESHOMA, THE PRIOR MESH (DEVICE 1) CONTRACTED INTO A MASS, THIS WAS DISSECTED. THERE WERE OMENTAL ADHESIONS OF THE PTFE SURFACE OF THE MESH, THESE WERE TAKEN DOWN. PALPATED THE AREA OF THE UMBILICUS, THERE WAS THE PREVIOUSLY PLACED UMBILICAL MESH. THIS UMBILICAL MESH (DEVICE 2) WAS ALSO DISSECTED OUT. A PHASIX MESH (DEVICE 3) WAS PLACED TO THE RETRO RECTUS AREA." ON (B)(6) 2019 - PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA CEPHALAD TO PREVIOUS REPAIR WITH NEW MESH.