PHASIX MESH

Description of Event or Problem

AS REPORTED PER THE CLINICAL TRIAL (B)(4). THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 AND UNDERWENT AN OPEN PRIMARY LAPAROTOMY SMALL BOWEL RESECTION AND OSTOMY CREATION/REVISION/REVERSAL DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH MECHANICAL SECURE STRAP. 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 0.26 CM FAR APART. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025, THE SUBJECT PATIENT DEVELOPED ABSCESS UNDER SKIN THAT NEEDED TO BE DRAINED. PATIENT ALSO DEVELOPED FEVER AND NOTICED DISCHARGE COMING FROM INCISION LINE. ABSCESS WAS DRAINED AND PACKED AND PATIENT WAS DISCHARGED FROM HOSPITAL (B)(6) 2025. ABSCESS RESOLVED; PACKING WILL GO ON FOR TWO TO THREE WEEKS. THE REPORTED ADVERSE EVENT (ABSCESS) HAS BEEN ASSESSED PER CLINICIANS AS PROBABLY RELATED TO THE STUDY DEVICE AND CAUSALLY TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY, THE REPORTED ADVERSE EVENT (ABSCESS) HAS BEEN ASSESSED AS RECOVERING/RESOLVING. THE REPORTED AE MEETS THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED AN ABSCESS POST IMPLANT OF A PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME (ABSCESS) AS PROBABLY RELATED TO THE STUDY DEVICE AND CAUSALLY TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THE LOT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. 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.