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. THIS EMDR REPRESENTS THE PHASIX MESH (DEVICE #1). ADDITIONAL SUPPLEMENTAL EMDR'S WERE SUBMITTED TO REPRESENT THE VENTRIO ST (DEVICE #2) AND ADDITIONAL EMDR'S WERE SUBMITTED TO REPRESENT THE PHASIX MESH (DEVICE #3 AND DEVICE #4). 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 PLAINTIFF PROFILE FORM (B)(4): ATTORNEY ALLEGES THAT THE PATIENT HAD ABSCESS, ADHESIONS, MESH MIGRATION, MESH SHRINKAGE, PAIN, HERNIA RECURRENCE WOUND VAC PLACED AND DRAIN PLACED. PER INFORMATION PROVIDED: (B)(6) 2015- PATIENT WAS DIAGNOSED WITH RECURRENT EPIGASTRIC INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PHASIX MESH (DEVICE #1), SMALL BOWEL RESECTION AND BILATERAL COMPONENT SEPARATION. PER OPERATIVE NOTES, "A SUBSTANTIAL DEFECT WAS NOTED AND A PRIMARY FASCIAL CLOSURE WAS PERFORMED. A BIOLOGIC MESH WAS PLACED AS IN FASCIAL UNDERLAY POSITION. A PHASIX MESH (DEVICE #1) WAS PLACED IN FASCIAL OVERLAY FASHION AND SECURED CIRCUMFERENTIALLY." (B)(6) 2016- PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, "INCISION MADE SHARPLY OVERLYING THE FASCIAL DEFECT CARRIED DOWN TO THE SAC AND OPENED. LYSIS OF ADHESIONS WAS PERFORMED. THE DEFECT WAS NOTED AND A VENTRIO ST MESH (DEVICE #2) WAS PLACED AND SUTURED. THE FASCIA WAS REAPPROXIMATED WITH SUTURE THROUGH THE IMMEDIATE UNDERLAY MESH (DEVICE #1)." (B)(6) 2016- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE #3). PER OPERATIVE NOTES, "BOWEL ADHESIONS WERE NOTED AND LYSED. THE FASCIA WAS REAPPROXIMATED WITH SUTURE AND THE DEFECT WAS MEASURED AND A PHASIX MESH (DEVICE #3) WAS TRIMMED AND PLACED AS A FASCIAL ONLAY AND SECURED." (B)(6) 2016- PATIENT WAS DIAGNOSED WITH MULTIPLE INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRIO ST MESH (DEVICE #2) AND IMPLANT OF PHASIX MESH (DEVICE #4). PER OPERATIVE NOTES, "OMENTAL AND BOWEL ADHESIONS WERE NOTED AND TAKEN DOWN. ADDITIONAL DEFECT WAS NOTED IN THE UMBILICUS. THE PREVIOUSLY PLACED VENTRIO ST MESH (DEVICE #2) WAS CONTRACTED AND WAS COMPLETELY REMOVED. A PHASIX MESH (DEVICE #4) WAS TACKED AND SUTURED." (B)(6) 2016- PATIENT WAS DIAGNOSED WITH ABDOMINAL WOUND INFECTION THEREBY UNDERWENT INCISION, DRAINAGE AND WOUND VAC PLACEMENT. PER OPERATIVE NOTES, "PURULENT NECROTIC FLUID WAS ASPIRATED AND THE MESH WAS IN PLACE WITH SOME NECROTIC SUBCUTANEOUS TISSUE." (B)(6) 2017- PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS THEREBY UNDERWENT DRAIN PLACEMENT.