PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, PATIENT WAS DIAGNOSED WITH AN INFECTED SEROMA (BACTERIAL) POST IMPLANT OF PHASIX MESH. THE ADVERSE EVENT (INFECTED SEROMA) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLE RELATED TO BOTH STUDY DEVICE AND PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE IN SEVERITY. 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 CONDITION CANNOT BE DETERMINED. SEROMA AND INFECTION ARE CLINICALLY UNDERSTOOD POTENTIAL COMPLICATIONS OF SURGERY/USE OF THE DEVICE AND ARE IDENTIFIED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, AS POSSIBLE COMPLICATIONS. ADDITIONALLY, THE WARNING SECTION STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION MAY REQUIRE THE REMOVAL OF THE MESH." 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 THE CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 AND UNDERWENT EXPLORATORY LAPAROTOMY FOR A COLOSTOMY AND LYSIS OF ADHESIONS DURING WHICH A PHASIX FLAT MESH WAS PLACED IN AN ONLAY FASHION AND SECURED USING ABSORBABLE MONOFILAMENT SUTURES AND CONCURRENTLY UNDERWENT AN OSTOMY/FISTULA TAKEDOWN. ERTAPENEM WAS ADMINISTERED PRIOR TO THE SURGERY AS A PROPHYLACTIC ANTIBIOTIC. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT CONTINUED SEROSANGUINOUS DRAINAGE. ON (B)(6) 2026, THE PATIENT WAS DIAGNOSED WITH BULGING AND FLUCTUANCE ALONG THE INCISION LINE BELOW THE UMBILICUS, WITH ASSOCIATED SKIN REDNESS. A CT SCAN OF THE ABDOMEN AND PELVIS REVEALED TWO FLUID COLLECTIONS: A LARGE SUBCUTANEOUS COLLECTION MEASURING 5.5 × 3.6 × 13.5 CM WITH INTERNAL FAT, AND A SMALLER 2.0 × 2.6 CM COLLECTION THAT COMMUNICATES WITH THE SKIN. AN INTERVENTIONAL RADIOLOGY DRAIN WAS PLACED, WITH 80 ML OF FLUID OUTPUT. CULTURE RESULTS FROM THE ABDOMINAL WOUND OPENING SHOWED RARE STAPHYLOCOCCUS LUGDUNENSIS. CULTURE FROM THE ABDOMINAL FLUID COLLECTION GREW FEW PROPIONIBACTERIUM (CUTIBACTERIUM) AVIDUM. THE PATIENT WAS TREATED WITH KEFLEX (CEPHALEXIN) 500 MG TWICE DAILY FOR 14 DAYS. AS REPORTED, THE ADVERSE EVENT (INFECTED SEROMA) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLE RELATED TO BOTH STUDY DEVICE AND PROCEDURE. THE SEVERITY HAS BEEN ASSESSED AS MODERATE. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).