PHASIX MESH

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4). THE SUBJECT PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2025 AND UNDERWENT OPEN RELAPAROTOMY, OSTOMY CREATION/REVISION/REVERSAL AND EXTENDED LEFT COLOPROCTECTOMY TO THE TRANSVERSE DURING WHICH A PHASIX FLAT MESH WAS TRIMMED, PLACED IN AN ONLAY FASHION AND SECURED USING 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 44CM IN LENGTH. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. AS REPORTED, ON (B)(6)2025 SUBJECT PATIENT WAS DIAGNOSED WITH SEROMA AND ADMITTED TO HOSPITAL. PATIENT UNDERWENT ABDOMINAL SCAN WHICH IDENTIFIED SUB UMBILICAL FLUID COLLECTION (55 X 28MM) AND HAD SEROMA EVACUATION UNDER LOCAL ANESTHESIA. PATIENT DISCHARGED FROM HOSPITAL ON (B)(6) 2025. AS REPORTED, THE ADVERSE EVENT (SEROMA) HAS BEEN ASSESSED PER CLINICIAN AS HAVING A CAUSAL RELATIONSHIP TO THE STUDY DEVICE AND TO THE PROCEDURE. THE SEVERITY HAS BEEN ASSESSED AS MILD. THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS RECOVERED/RESOLVED. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND UADE (UNANTICIPATED ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED SEROMA POST IMPLANT OF A PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME (SEROMA) TO HAVE A CAUSAL RELATIONSHIP TO THE STUDY DEVICE AND TO THE PROCEDURE AND RECOVERED/RESOLVED. HOWEVER, BASED ON THE INFORMATION PROVIDED, THE EXTENT TO WHICH THE PHASIX MESH IMPLANT USED TO TREAT THE PATIENT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT'S POSTOPERATIVE SEROMA IS UNKNOWN. HENCE, NO CONCLUSIONS CAN BE MADE. SEROMA FORMATION IS A CLINICALLY UNDERSTOOD POTENTIAL COMPLICATION OF SURGERY/USE OF THE DEVICE AND IS IDENTIFIED IN THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, AS A POSSIBLE COMPLICATION. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT 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.