PHASIX MESH

Description of Event or Problem

PER INFORMATION PROVIDED: (B)(6) 2002 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE #1) AND COMPOSIX MESH (DEVICE #2). PER OP NOTES, "A BARD FLAT MESH (DEVICE #1) AND COMPOSIX MESH (DEVICE #2) WAS PLACED AND SUTURED." (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH INFECTED MESH THEREBY UNDERWENT EXPLANT OF BARD FLAT MESH (DEVICE #1) AND COMPOSIX MESH (DEVICE #2). PER OP NOTES, "MULTIPLE ADHESIONS WERE LYSED. THE BARD FLAT MESH (DEVICE #1) AND COMPOSIX MESH (DEVICE #2) WERE EXCISED." (B)(6) 2003 - PATIENT WAS DIAGNOSED WITH WOUND EVISCERATION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, "A SYNTHETIC MESH WAS PLACED AND SUTURED." (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, "A SYNTHETIC MESH WAS PLACED AND SUTURED." (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH LARGE VENTRAL HERNIA WITH FISTULA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF SYNTHETIC MESHES AND IMPLANT OF BIOLOGICAL MESH. PER OP NOTES, "THE MESH ADHERENT TO THE BOWEL WAS TAKEN DOWN. THE PREVIOUSLY PLACED SYNTHETIC MESHES WERE EXCISED. A BIOLOGICAL MESH WAS PLACED AND SUTURED." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT ROBOTIC CONVERTED TO OPEN REPAIR WITH EXPLANT OF BIOLOGICAL MESH AND IMPLANT OF PHASIX MESH (DEVICE #3). PER OP NOTES, "THE BIOLOGICAL MESH PREVIOUSLY PLACED SEEN TO BE PULLED AWAY WAS DISSECTED AND REMOVED. A PHASIX MESH (DEVICE #3) WAS PLACED AND SUTURED." (B)(6) 2018 - PATIENT UNDERWENT DRAINAGE OF ABDOMINAL WALL SEROMA.

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-AUG-2017) IS CONSIDERED TO BE A BEST ESTIMATE. THIS EMDR REPRESENTS THE BARD PHASIX MESH (DEVICE #3). ADDITIONAL SUPPLEMENTAL EMDR'S WERE SUBMITTED TO REPRESENT THE BARD FLAT MESH (DEVICE #1) AND BARD MESH - COMPOSIX (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.