PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED SEROMA POST IMPLANT OF A PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. POST SURGICAL SEROMA IS A CLINICALLY UNDERSTOOD POTENTIAL COMPLICATION OF SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS A POSSIBLE COMPLICATION. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. 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 EXPLORATORY LAPAROTOMY, WITH CONCOMITANT HYSTERECTOMY & OOPHORECTOMY WITH IMPLANT OF PHASIX MESH AS AN ONLAY ON (B)(6)2024. THE MESH WAS TRIMMED TO 22CM AND CLOSED WITH ABSORBING MONOFILAMENT SUTURE; PATIENT WAS DISCHARGED ON (B)(6)2024. THE SUBJECT PATIENT RETURNED FOR 1ST POST-OP VISIT ON (B)(6)2025, WAS DIAGNOSED WITH UTI AND WAS PRESCRIBED CIPRO AND LATER BACTRIM. THE PATIENT PRESENTED TO THE ED ON (B)(6)2025, WITH NOTED DRAINAGE AND DISCHARGE FROM THE SURGICAL INCISION SITE; UPON ARRIVAL, WOUND CULTURES WERE COLLECTED. CT DEMONSTRATED POSTOPERATIVE SEROMA VERSUS AN ABSCESS. THE SUBJECT'S INCISION WAS OPENED AT THE BEDSIDE, AND WET & DRY DRAPES WERE APPLIED. THE PATIENT WAS ALSO MANAGED WITH A CEFEPIME AND VANCOMYCIN AND THERE WAS NO PLAN FOR IR DRAINAGE. THE SUBJECT HAD ADDITIONAL WOUND PACKING ON (B)(6)2025 AND WAS PLANNED FOR DISCHARGE WITH HOME NURSING SCHEDULED FOR AT-HOME WOUND CARE. THE ADVERSE EVENT RESOLVED ON 14-JAN-2025. THE REPORTED ADVERSE EVENT (SEROMA) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE, POSSIBLY RELATED TO THE PROCEDURE AND HAS RECOVERED/RESOLVED. THE AE HAS BEEN ASSESSED AS SEVERE. THE REPORTED AE MEETS THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF UADE (UNANTICIPATED ADVERSE DEVICE EVENT).