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 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.

Description of Event or Problem

PER INFORMATION PROVIDED: ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OPERATIVE NOTES, "A VERTICAL INCISION WAS MADE THROUGH THE MIDLINE SCAR OVERLYING THE HERNIA IN THE EPIGASTRIUM. THE HERNIA SAC WAS DISSECTED OUT. A VENTRALEX ST MESH (DEVICE 1) WAS PLACED INTO THE DEFECT AND CLOSED THE DEFECT WITH SUTURES." ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA HEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PHASIX MESH (DEVICE 2) AND EXPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OPERATIVE NOTES, "AN INCISION WAS MADE IN THE MID EPIGASTRIUM THROUGH PRIOR HEALED INCISION SITE. THE HERNIA SAC WAS DISSECTED OUT. PREVIOUSLY PLACED VENTRALEX ST MESH (DEVICE 1) WAS IDENTIFIED WHICH WAS DISSECTED OUT. A PHASIX MESH (DEVICE 2) WAS PLACED INTO THE DEFECT AND CLOSED THE DEFECT WITH SUTURES." ON (B)(6) 2021 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PHASIX MESH (DEVICE 3). PER OPERATIVE NOTES, "THE PREVIOUS MIDLINE INCISION WAS CAREFULLY REOPENED. THE HERNIA SAC WAS DISSECTED OUT. PREVIOUSLY PLACED (DEVICE 2) WAS NOT IDENTIFIED IN THIS PROCEDURE. DENSE ADHESIONS WERE OBSERVED, WHICH WERE DISSECTED OUT. A PHASIX MESH (DEVICE 3) WAS PLACED INTO THE ABDOMINAL WALL AND CLOSED THE DEFECT WITH SUTURES."