PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED AN INCISIONAL HERNIA POST IMPLANT OF THE PHASIX MESH USED AS A ONLAY TO SUPPORT THE ABDOMEN FOLLOWING A COMPLEX SURGERY. REPORTEDLY, THE PATIENT HAD BEEN COUGHING A LOT AND SUDDENLY A PROTRUSION APPEARED IN THE UPPER QUARTER OF THE LAPAROTOMY SCAR. SONOGRAPHY IDENTIFIED AN INCISIONAL HERNIA. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS POSSIBLY/CAUSALLY RELATED TO THE STUDY DEVICE WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO DEFINITIVE CONCLUSIONS CAN BE MADE. 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 (B)(4): THE SUBJECT PATIENT UNDERWENT MULTIPLE PROCEDURES ON (B)(6) 2023 INCLUDING AN OPEN COLECTOMY, OSTOMY CREATION/REVISION/REVERSAL, RESECTION OF THE BLADDER AND PROSTATE, AND CREATION OF AN ILEUM CONDUIT. A TRIMMED PHASIX MESH ONLAY WAS PLACED AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBABLE MONOFILAMENT 2 PDS SUTURES. PATIENT HAD COLOSTOMY AND ILEUM CONDUIT/UROSTOMY IN THE INDEX OPERATION. ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE HOSPITAL AS AN EXSICCATED PATIENT WITH ACUTE KIDNEY INJURY AND RECEIVED FLUIDS TO IMPROVE HIS VALUES. REGULAR PERIANAL WOUNDS CONTROLS AND STOMA CHANGES WERE CARRIED OUT. ON (B)(6) 2025, IT WAS IDENTIFIED THE PATIENT HAD WOUND DEFECT LEFT LATERAL OF OSTOMY. CLEANING OF THE WOUND, APPLICATION OF AQUACEL AND COMFEEL WERE CARRIED OUT. ALSO, THE PATIENT HAD BEEN COUGHING A LOT RECENTLY. SUDDENLY A PROTRUSION APPEARED IN THE UPPER QUARTER OF THE LAPAROTOMY SCAR. SONOGRAPHY WAS TAKEN AND IDENTIFIED AN INCISIONAL HERNIA WITH 5 CM DIAMETER. THE REPORTED ADVERSE EVENT (INCISIONAL HERNIA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY AND CAUSALLY RELATED TO THE STUDY DEVICE AND A CAUSAL RELATIONSHIP TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY, AND IT IS RECOVERING/RESOLVING.