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-DEC-2017) IS CONSIDERED TO BE A BEST ESTIMATE. THIS EMDR REPRESENTS THE BARD/DAVOL PHASIX MESH (DEVICE #3). ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRALEX ST (DEVICE #2) AND AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT BARD/DAVOL COMPOSIX KUGEL (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 ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED OUT. A SMALL PIECE OF COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED AGAINST THE POSTERIOR SURFACE OF THE ANTERIOR ABDOMINAL WALL AND SUTURED.¿ ON (B)(6) 2015 ¿ PATIENT HAD ABDOMINAL CELLULITIS WITH POSSIBLE MRSA THEREBY UNDERWENT RESECTION OF CHRONICALLY INFECTED ABDOMINAL WALL INTRAPERITONEAL MESH (DEVICE 1) AND PRIMARY CLOSURE OF FASCIAL DEFECT. THE COMPOSIX KUGEL MESH (DEVICE 1) WAS REMOVED.¿ (NOTE: THERE IS NO OP NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RIGHT UPPER QUADRANT PAIN AND RECURRENT VENTRAL ABDOMINAL WALL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS EXCISED. SCARRING WAS NOTED. A VENTRALEX ST MESH (DEVICE 2) WAS PLACED INTO THE PERITONEAL CAVITY AND SECURED TO THE FASCIA USING SUTURES.¿ ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RIGHT INDIRECT INGUINAL HERNIA AND SMALL DIRECT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESH. ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT RIGHT INGUINAL HERNIA, MESHOMA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF SYNTHETIC MESH AND AN IMPLANT OF PHASIX FLAT MESH (DEVICE 3). PER OPERATIVE NOTES, ¿SCARRING WAS NOTED. THE SYNTHETIC MESH WAS REMOVED. THE ILIOINGUINAL NERVE, ILIOHYPOGASTRIC NERVE AND GENITOFEMORAL NERVES WERE DISSECTED OUT AND LIGATED. THE LAXITY OF THE INGUINAL FLOOR WAS REPAIRED USING PHASIX FLAT MESH (DEVICE 3) AND SUTURED.¿ ON (B)(6) 2018 ¿ PATIENT HAD CHRONIC PAIN, INFLAMMATION, CELLULITIS AND WAS DIAGNOSED WITH RECURRENT INCISIONAL INCARCERATED HERNIA, MESHOMA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF VENTRALEX ST MESH (DEVICE 2) AND IMPLANT OF PHASIX MESH (DEVICE 4). PER OPERATIVE NOTES, ¿ADHESIONS WERE TAKEN DOWN. THE VENTRALEX ST MESH (DEVICE 2) WAS REMOVED. A PHASIX MESH (DEVICE 4) WAS PLACED INTRAABDOMINALLY USING SUTURES. ON (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED. THE SCARRING FROM PREVIOUS MESH (DEVICE 3) WAS NOTED. ON (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH RIGHT ILIOINGUINAL NERVE NEURALGIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF PHASIX FLAT MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THE FLOOR OF THE INGUINAL CANAL WAS COMPLETELY SCARRED WITH MESH. A LARGE TRUNK OF THE MESH (DEVICE 3) WAS REMOVED.¿