PHASIX MESH

Description of Event or Problem

AS REPORTED PER PREVENT CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT UNDERWENT A COLECTOMY PRIMARY LAPAROTOMY LAPAROSCOPIC UMBILICAL PROCEDURE ON (B)(6) 2025, DURING WHICH PHASIX MESH ONLAY WAS TRIMMED AND IMPLANTED USING ABSORBABLE MONOFILAMENT SUTURE. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBING MONOFILAMENT SUTURES. THE SUBJECT PATIENT DIAGNOSED WITH A SUBCUTANEOUS ABSCESS ON (B)(6) 2025. ACTION TAKEN IS LISTED AS "NURSING CARE." AS REPORTED, THE ADVERSE EVENT (SUBCUTANEOUS ABSCESS) HAS BEEN ASSESSED PER CLINICIAN (STUDY SITE INVESTIGATOR) AS CAUSAL RELATIONSHIP TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE AND NOT RECOVERED/RESOLVED. THE ADVERSE EVENT HAS BEEN ASSESSED PER CLINICIAN (MEDICAL MONITOR) AS PROBABLY RELATED TO THE STUDY DEVICE AND CAUSAL RELATIONSHIP TO THE PROCEDURE. THE AE HAS BEEN ASSESSED AS MODERATE IN SEVERITY. THE REPORTED AE DOES NOT MEET 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 PATIENT WAS DIAGNOSED WITH A SUBCUTANEOUS ABSCESS POST IMPLANT OF PHASIX MESH. THE CLINICIAN (MEDICAL MONITOR) HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE OF SUBCUTANEOUS ABSCESS AS PROBABLY RELATED TO THE STUDY DEVICE WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE MADE. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT 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.