PHASIX MESH

Description of Event or Problem

AS REPORTED, PATIENT WAS IMPLANTED WITH PHASIX MESH ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NUMEROUS COMPLICATIONS AND HAS UNDERGONE MULTIPLE PROCEDURES SINCE THE IMPLANT PROCEDURE. THE PATIENT HAS INTERMITTENT DRAINAGE FROM THE ABDOMINAL WALL AT FOUR LOCATIONS AND CULTURED FOR METHICILLIN-RESISTANT STAPH AUREUS AND HAS BEEN TREATED WITH ANTIBIOTICS. IT WAS REPORTED THAT THE PATIENT'S SINUSES HAVE INTERMITTENTLY HEALED AND REOPENED. IT WAS REPORTED THAT THEY DISCUSSED POSSIBLY REPEATING A CT SCAN OF THE ABDOMEN TO ASSESS FOR UNDRAINED FLUID COLLECTIONS.

Additional Manufacturer Narrative

AS REPORTED, PATIENT HAD INFECTION, SEROMA, PURULENT DISCHARGE POST IMPLANT OF PHASIX MESH. BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE DEVICE USED IN THE PROCEDURE MAY HAVE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS INFECTION AND SEROMA AS POSSIBLE COMPLICATIONS. IN REGARD TO INFECTION, 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 REMOVAL OF THE DEVICE." NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT IS CONSIDERED TO BE A BEST ESTIMATE AS (B)(6) 2025 BASED ON THE DATE OF AWARENESS. 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."