PHASIX MESH

Description of Event or Problem

INITIAL EMDR - PER INFORMATION PROVIDED: ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH. PER OPERATIVE NOTES, ¿TISSUE PROTRUDING THROUGH THE HERNIA DEFECT, WHICH WERE DISSECTED OFF THE SURROUNDING ADHESIONS AND PUSHED BACK INTO THE PERITONEAL CAVITY. A VENTRALEX ST MESH (DEVICE #1) WAS PLACED IN THE RETROPERITONEAL POSITION USING SUTURE.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PHASIX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE CONTENTS OF THE HERNIA WERE IDENTIFIED. ADHESIOLYSIS WAS PERFORMED. THE OLD VENTRALEX ST MESH (DEVICE #1) WAS DISSECTED FREE FROM THE ABDOMINAL WALL. THE RECURRENT HERNIA WAS INFERIOR TO THE MESH AND SAC WAS EXCISED. MYOFASCIAL ADVANCEMENT FLAP WAS PERFORMED. THE PHASIX MESH (DEVICE #2) WAS THEN ATTACHED LATERALLY TO THE EDGE OF THE EXTERNAL OBLIQUE USING SUTURE.¿ ON (B)(6) 2022 - PATIENT HAD HERNIA RECURRENCE, ADHESION, INFLAMMATION AND PAIN THEREBY UNDERWENT MESH REVISION. (NOTE: THERE IS NO INFORMATION WAS PROVIDED IN MEDICAL RECORD).

Additional Manufacturer Narrative

BASED ON THE ADDITIONAL INFORMATION RECEIVED, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 5 YEARS AND 5 MONTHS POST IMPLANT OF PHASIX MESH, PATIENT WAS DIAGNOSED WITH HERNIA, ADHESION, INFLAMMATION AND PAIN. THE INSTRUCTION OF USE SUPPLIED ALONG WITH DEVICE LISTS RECURRENCE OF HERNIA, HERNIA, ADHESION, INFLAMMATION AND PAIN AS POSSIBLE COMPLICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. NOTE, THE MANUFACTURING DATE (15-NOV-2016) IS CONSIDERED TO BE A BEST ESTIMATE. THIS EMDR REPRESENT THE PHASIX MESH (DEVICE #2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENTS THE VENTRALEX ST (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. H3 OTHER TEXT: NOT RETURNED.