PHASIX MESH

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 AND UNDERWENT AN OPEN RELAPAROTOMY COLECTOMY AND LYSIS OF ADHESION 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. ON (B)(6) 2026, THE SUBJECT PATIENT DEVELOPED PROLONGED ILEUS. PATIENT RECEIVED A PICC LINE TO INITIATE TOTAL PARENTERAL NUTRITION. ON (B)(6) 2026, THE PATIENT WAS DISCHARGED FROM HOSPITAL. THE REPORTED ADVERSE EVENT (PROLONGED ILEUS) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE IN SEVERITY; 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). ADDENDUM: EVENT TERM CORRECT TO "POSTOPERATIVE" ILEUS. THE DATE EVENT WAS UPDATED TO (B)(6) 2026. THE REPORTED ADVERSE EVENT (POSTOPERATIVE ILEUS) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE AND THE ADVERSE EVENT WAS RECOVERED/RESOLVED ON (B)(6) 2026. IT HAS BEEN ASSESSED AS SEVERE IN SEVERITY.

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT WAS DIAGNOSED WITH PROLONGED ILEUS POST IMPLANT OF A PHASIX MESH AS AN ONLAY. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE 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. 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. ADDENDUM: H11: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED TO DOCUMENT ADDITIONAL/CORRECTED INFORMATION. AS REPORTED, THE SUBJECT PATIENT WAS DIAGNOSED WITH POSTOPERATIVE ILEUS POST IMPLANT OF A PHASIX MESH AS AN ONLAY. THIS CONDITION HAS RESOLVED. NO CONCLUSIONS CAN BE MADE; 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. UPDATED FIELDS: B4, B7, G3, G6, H2, H4, H6, H10, H11. CORRECTED FIELDS: B3 (DATE OF EVENT), B5. 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.

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT WAS DIAGNOSED WITH PROLONGED ILEUS POST IMPLANT OF A PHASIX MESH AS AN ONLAY. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE 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. 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 122 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.

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 AND UNDERWENT AN OPEN RELAPAROTOMY COLECTOMY AND LYSIS OF ADHESION 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. ON (B)(6) 2026, THE SUBJECT PATIENT DEVELOPED PROLONGED ILEUS. PATIENT RECEIVED A PICC LINE TO INITIATE TOTAL PARENTERAL NUTRITION. ON (B)(6) 2026, THE PATIENT WAS DISCHARGED FROM HOSPITAL. THE REPORTED ADVERSE EVENT (PROLONGED ILEUS) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE IN SEVERITY; 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).