PHASIX MESH

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 AND UNDERWENT AN OPEN PRIMARY LAPAROTOMY FREY'S PROCEDURE WITH WIRSUNGO-JEJUNAL ANASTOMOSIS ON THE REMAINING PANCREAS AFTER CLEARING OF THE HEAD OF THE PANCREAS, WITHOUT GASTROENTERO ANASTOMOSIS AND CHOLECYSTECTOMY DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MONOFILAMENT SUTURES. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBING MONOFILAMENT WITH RUNNING STITCHES APPROXIMATELY 1 CM FAR APART AND 43CM IN LENGTH. ON (B)(6) 2025, THE SUBJECT PATIENT DEVELOPED SUBCUTANEOUS HEMATOMA AND BED SITE HEMATOMA EVACUATION WAS PERFORMED. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025, THE SUBJECT PATIENT DEVELOPED SUBCUTANEOUS SEROMA WITH MIDLINE LAPAROTOMY 1 CM DESUNION (DEHISCENCE); THE SEROMA WAS EVACUATED AT BEDSIDE DURING USV. THE REPORTED ADVERSE EVENTS (SUBCUTANEOUS HEMATOMA AND SUBCUTANEOUS SEROMA) HAVE BEEN ASSESSED PER CLINICIANS AS CAUSALLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. THEY HAVE BEEN ASSESSED AS MILD IN SEVERITY; THE REPORTED ADVERSE EVENT (SUBCUTANEOUS HEMATOMA) HAS BEEN ASSESSED AS RECOVERING/RESOLVING. THE REPORTED AES DO NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED A SEROMA (WITH 1 CM DEHISCENCE) AND HEMATOMA POST IMPLANT OF A PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS CAUSALLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. SEROMA, WOUND DEHISCENCE AND HEMATOMA FORMATION ARE CLINICALLY UNDERSTOOD POTENTIAL COMPLICATIONS OF SURGERY/USE OF THE DEVICE AND ARE IDENTIFIED IN THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, AS POSSIBLE COMPLICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THE LOT WAS MANUFACTURED TO SPECIFICATION. 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.