PHASIX MESH

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 ON (B)(6) 2025 UNDERWENT AN OPEN RELAPAROTOMY COLECTOMY AND TRUE OSTOMY CREATION/REVISION/REVERSAL DURING WHICH A PHASIX MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MULTIFILAMENT SUTURES. 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 1 CM FAR APART AND 53CM IN LENGTH. ON (B)(6) 2025, THE SUBJECT PATIENT DEVELOPED SUBCUTANEOUS SEROMA WITH MIDLINE LAPAROTOMY SCAR DESUNION (DEHISCENCE). PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. THE REPORTED ADVERSE EVENT (SUBCUTANEOUS SEROMA WITH MIDLINE LAPAROTOMY SCAR DESUNION) HAS BEEN ASSESSED PER CLINICIANS AS CAUSALLY 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: ON (B)(6) 2025, THE SUBJECT PATIENT DEVELOPED SUBCUTANEOUS SEROMA AND HAD EVACUATION OF SEROMA AT THE BEDSIDE, PACKING AND LOCAL CARE, DRAINS ON THE SAME DAY. SUBCUTANEOUS SEROMA RESOLVED ON (B)(6) 2025. THE SEROMA HAS BEEN ASSESSED AS MODERATE IN SEVERITY. ON (B)(6) 2025, THE SUBJECT PATIENT DEVELOPED PERSISTENT WOUND SURGICAL DEHISCENCE UNTIL THE DEVICE WAS PARTIALLY REMOVED DURING THE USV CONSULTATION ON (B)(6) 2025 AT THE BEDSIDE WITHOUT ANESTHESIA. DURING A CONSULTATION ON (B)(6) 2025 IT WAS STATED THAT SMALL THREADS OF MESH THAT WERE STICKING OUT WERE ALSO REMOVED 3 TIMES BY PATIENT'S NURSES AT HOME. CONSULTATION ON (B)(6) 2025 HAS CONFIRMED THE EPITHELIALIZATION IN PROGRESS AND DEVICE NO LONGER VISIBLE. THE REPORTED ADVERSE EVENT (WOUND SURGICAL (MIDLINE LAPAROTOMY) DEHISCENCE) HAS BEEN ASSESSED PER CLINICIANS AS CAUSALLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE 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).

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED A SEROMA WITH MIDLINE LAPAROTOMY SCAR DESUNION (DEHISCENCE) POST IMPLANT OF PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS CAUSALLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. SEROMA FORMATION AND WOUND DEHISCENCE ARE CLINICALLY UNDERSTOOD POTENTIAL COMPLICATIONS OF SURGERY/USE OF THE DEVICE AND ARE IDENTIFIED IN THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, AS POSSIBLE COMPLICATIONS. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ADDENDUM: THIS IS AN ADDENDUM TO THE INITIAL MDR SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE MESH WAS PARTIALLY REMOVED. THE REPORTED ADVERSE EVENTS (SEROMA AND WOUND SURGICAL (MIDLINE LAPAROTOMY) DEHISCENCE) HAVE BEEN ASSESSED PER CLINICIANS AS CAUSALLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. ASSESSED AS MODERATE IN SEVERITY; THE SEROMA HAS RESOLVED AND THE DEHISCENCE HAS BEEN ASSESSED AS RECOVERING/RESOLVING. BASED ON THE INFORMATION PROVIDED, WE CANNOT DRAW ANY CONCLUSIONS REGARDING THE EXTENT TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S POSTOPERATIVE OUTCOME. 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 DEVELOPED A SEROMA WITH MIDLINE LAPAROTOMY SCAR DESUNION (DEHISCENCE) POST IMPLANT OF PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS CAUSALLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. SEROMA FORMATION AND WOUND DEHISCENCE ARE CLINICALLY UNDERSTOOD POTENTIAL COMPLICATIONS OF SURGERY/USE OF THE DEVICE AND ARE IDENTIFIED IN THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, AS POSSIBLE COMPLICATIONS. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE DEVICE 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 DVL-HE-018: THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 AND ON (B)(6) 2025 UNDERWENT AN OPEN RELAPAROTOMY COLECTOMY AND TRUE OSTOMY CREATION/REVISION/REVERSAL DURING WHICH A PHASIX MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH ABSORBABLE MULTIFILAMENT SUTURES. 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 1 CM FAR APART AND 53CM IN LENGTH. ON (B)(6) 2025, THE SUBJECT PATIENT DEVELOPED SUBCUTANEOUS SEROMA WITH MIDLINE LAPAROTOMY SCAR DESUNION (DEHISCENCE). PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. THE REPORTED ADVERSE EVENT (SUBCUTANEOUS SEROMA WITH MIDLINE LAPAROTOMY SCAR DESUNION) HAS BEEN ASSESSED PER CLINICIANS AS CAUSALLY 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).