PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN POST IMPLANT OF A PHASIX MESH AS AN ONLAY. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE ABDOMINAL PAIN AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. 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 PAIN IS UNKNOWN. HENCE, NO CONCLUSIONS CAN BE MADE. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. PAIN IS LISTED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, PROVIDED WITH THE DEVICE. ADDENDUM: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED TO DOCUMENT THE ADDITIONAL INFORMATION PROVIDED. AS REPORTED, THE SUBJECT PATIENT DEVELOPED SMALL BOWEL OBSTRUCTION POST IMPLANT OF A PHASIX MESH AS AN ONLAY. THE CLINICIAN HAS ASSESSED THE PATIENT'S POSTOPERATIVE BOWEL OBSTRUCTION AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. 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 COURSE IS UNKNOWN. HENCE, NO CONCLUSIONS CAN BE MADE. UPDATED FIELDS: B4, B5, B7, G3, G6, H1, H2, H6, H10. 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 THE HOSPITAL ON (B)(6) 2025 AND UNDERWENT AN OPEN LAPAROSCOPIC PRIMARY LAPAROTOMY COLOSTOMY TAKEDOWN AND SIGMOIDOSCOPY DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MULTIFILAMENT SUTURES WITH 2-0 PDS. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBABLE MONOFILAMENT 1 PDS SUTURES. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. ON (B)(6) 2026, THE SUBJECT PATIENT DEVELOPED ABDOMINAL PAIN. NO FURTHER ACTION WAS TAKEN. THE REPORTED ADVERSE EVENT (ABDOMINAL PAIN) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY; THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS RECOVERING/RESOLVING. THE REPORTED AES DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT). ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2026, THE SUBJECT PATIENT DEVELOPED SMALL BOWEL OBSTRUCTION. NO FURTHER ACTION WAS TAKEN. THE REPORTED ADVERSE EVENT (SMALL BOWEL OBSTRUCTION) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. IT HAS BEEN ASSESSED AS SEVERE IN SEVERITY; THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS NOT RECOVERED/NOT RESOLVED. THE REPORTED AES 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 WAS DIAGNOSED WITH ABDOMINAL PAIN POST IMPLANT OF A PHASIX MESH AS AN ONLAY. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE ABDOMINAL PAIN AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. 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 PAIN IS UNKNOWN. HENCE, NO CONCLUSIONS CAN BE MADE. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. PAIN IS LISTED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, PROVIDED WITH THE DEVICE. 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)(6): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 AND UNDERWENT AN OPEN LAPAROSCOPIC PRIMARY LAPAROTOMY COLOSTOMY TAKEDOWN AND SIGMOIDOSCOPY DURING WHICH A PHASIX FLAT MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MULTIFILAMENT SUTURES WITH 2-0 PDS. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBABLE MONOFILAMENT 1 PDS SUTURES. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. ON (B)(6) 2026, THE SUBJECT PATIENT DEVELOPED ABDOMINAL PAIN. NO FURTHER ACTION WAS TAKEN. THE REPORTED ADVERSE EVENT (ABDOMINAL PAIN) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY; THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS RECOVERING/RESOLVING. THE REPORTED AES DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).