PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT WAS DIAGNOSED WITH AN ANTERIOR ABDOMINAL FLUID ABSCESS POSITIVE FOR BACTERIAL INFECTION POST IMPLANT OF PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE AS POSSIBLY RELATED TO THE STUDY DEVICE WITH CAUSALLY RELATED TO THE PROCEDURE AND IS RECOVERING/RESOLVING. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. INFECTION IS A CLINICALLY UNDERSTOOD POTENTIAL COMPLICATION OF SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE (IFU), SUPPLIED WITH THE DEVICE AS A POSSIBLE COMPLICATION. THE WARNINGS SECTION IN IFU 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 SHOWS THE PRODUCT WAS MADE 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 AN OPEN EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION, MESENTERIC LYMPH NODE DISSECTION, FLUORESCEIN ANGIOGRAPHY, APPENDECTOMY AND OMENTAL PEDICLE FLAP ON (B)(6) 2025, DURING WHICH THE PHASIX MESH ONLAY WAS TRIMMED AND IMPLANTED USING 2-0 PDS ABSORBABLE MONOFILAMENT SUTURE. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBING MONOFILAMENT 0 PDS SUTURES; AT 1CM APART. ON (B)(6) 2025, THE SUBJECT PATIENT HAD FEVER AND SWEATING; PATIENT TESTED NEGATIVE FOR COVID AND FLU. ON (B)(6) 2025, THE PATIENT VISITED THE HOSPITAL AND UNDERWENT ABDOMINAL EXAMINATION WHICH DIAGNOSED A POTENTIAL INTRA-ABDOMINAL FLUID COLLECTION OR ABSCESS. SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT CT SCAN. THE SCAN RESULTS FINDS THAT THE PATIENT HAD A VERY LARGE GAS AND FLUID CONTAINING COLLECTION IN ANTERIOR ABDOMINAL WALL, CONCERNING FOR ABSCESS. ANTIBIOTICS (ZOSYN AND VANC) WERE STARTED AND CONSULT TO IR PLACED FOR DRAINAGE OF FLUID. ON (B)(6) 2025, PATHOLOGY FOR CULTURE TAKEN WAS GRAM POSITIVE COCCI IN CLUSTERS (BACTERIAL INFECTION). AS REPORTED, THE ADVERSE EVENT HAS BEEN ASSESSED PER CLINICIAN (STUDY SITE INVESTIGATOR) AS POSSIBLY RELATED TO THE STUDY DEVICE WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE AND IS RECOVERING/RESOLVING. THE AE HAS BEEN ASSESSED AS SEVERE IN SEVERITY. THE REPORTED AE DOES MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).