PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED WOUND DEHISCENCE POST IMPLANT OF PHASIX MESH PLACED IN AN ONLAY FASHION. THE REPORTED WOUND DEHISCENCE HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE IN SEVERITY AND IT IS RECOVERING/RESOLVING. HOWEVER, BASED ON THE INFORMATION PROVIDED THE DEGREE TO WHICH THE PHASIX MESH IMPLANT USED TO TREAT THE PATIENT, MAY HAVE CAUSED, OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE IS UNKNOWN. WOUND DEHISCENCE 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.

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT WAS ADMITTED TO HOSPITAL ON (B)(60 2026 AND ON (B)(6) 2026 PATIENT UNDERWENT AN PRIMARY LAPAROTOMY OPEN COLECTOMY, OSTOMY CREATION/REVISION/REVERSAL, LYSIS OF ADHESION DURING WHICH A PHASIX MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH SUTURES. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ABSORBABLE MONOFILAMENT 2 PDS SUTURES. PATIENT HAD THE HISTORY OF ABDOMINAL OR PELVIC ILLNESS AND PREVIOUS POSTOPERATIVE INFECTIONS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2026. ON (B)(6) 2026 PATIENT WAS DIAGNOSED WITH WOUND DEHISCENCE AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026. THE SUBJECT PATIENT HAD WOUND DEHISCENCE MEASURED APPROXIMATELY 2 CM X 5 MM. NO SIGNS OF INFECTION WERE OBSERVED. PUS WAS DRAINING FROM THE WOUND, AND FIBRIN WAS VISIBLE INSIDE. DAILY WOUND CHECKS AND LAVAGE DONE ON (B)(6) 2026 AND (B)(6) 2026 WITH ACTIMARIS, INSERTION OF BIATAIN AG TAMPONADE STRIPS. THE SUBJECT PATIENT HAD PRESACRAL ABSCESS (CLINICALLY ASSESSED AS UNRELATED TO THE STUDY DEVICE) AND WOUND DEHISCENCE THEREBY PLANNED SURGICAL INTERVENTION ON (B)(6) 2026. THE REPORTED ADVERSE EVENT (WOUND DEHISCENCE) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND A CAUSAL RELATIONSHIP TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, AND IT IS RECOVERING/RESOLVING. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).