PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED A LARGE WOUND HEMATOMA POST IMPLANT OF A PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. A LOT NUMBER WAS NOT PROVIDED, AS SUCH A REVIEW OF THE MANUFACTURING RECORDS CANNOT BE CONDUCTED. HEMATOMA IS LISTED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE. ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE DATE OF EVENT. UPDATED FIELDS: B4, B5, G3, G6, H2, H10, H11. CORRECTED FIELD: B3 (DATE OF EVENT). 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 WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 AND ON (B)(6) 2025 UNDERWENT AN OPEN PRIMARY LAPAROTOMY COLOSTOMY TAKEDOWN AND CYSTOSCOPY WITH INSERTION OF URETERAL STENT(S) DURING WHICH A PHASIX FLAT MESH WAS PLACED. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025, THE STAT CT SCAN SHOWED THAT THE SUBJECT PATIENT DEVELOPED LARGE WOUND HEMATOMA MEASURING 21.3CM X 12 X 6 IN THE BELLY AND ON (B)(6) 2025 PATIENT WAS ADMITTED TO THE HOSPITAL AND WILL BE TAKEN BACK TO THE OR TO WASH OUT THE HEMATOMA. ADDENDUM: RECOVERY WAS COMPLICATED BY A WOUND HEMATOMA. THE HEMATOMA WAS DRAINED A LITTLE BIT THROUGH A SMALL OPENING NEXT TO THE UMBILICUS. PLAN WAS TO ENLARGE THE OPENING AND EVACUATE THE HEMATOMA. THE PATIENT DID NOT RECEIVE OR REQUIRE ANTIBIOTICS. LARGE WOUND HEMATOMA RESOLVED ON (B)(6) 2025. THE REPORTED ADVERSE EVENT (LARGE WOUND HEMATOMA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE IN SEVERITY; THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS RECOVERED/RESOLVED. THE REPORTED AE MEETS THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT DEVELOPED A LARGE WOUND HEMATOMA POST IMPLANT OF A PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE OUTCOME AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. A LOT NUMBER WAS NOT PROVIDED, AS SUCH A REVIEW OF THE MANUFACTURING RECORDS CANNOT BE CONDUCTED. HEMATOMA IS LISTED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE. 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 WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 AND ON (B)(6) 2025 UNDERWENT AN OPEN PRIMARY LAPAROTOMY COLOSTOMY TAKEDOWN AND CYSTOSCOPY WITH INSERTION OF URETERAL STENT(S) DURING WHICH A PHASIX FLAT MESH WAS PLACED. PATIENT WAS DISCHARGED FROM HOSPITAL ON (B))(6) 2025. ON (B)(6) 2025, THE STAT CT SCAN SHOWED THAT THE SUBJECT PATIENT DEVELOPED LARGE WOUND HEMATOMA MEASURING 21.3CM X 12 X 6 IN THE BELLY AND ON (B)(6) 2025 PATIENT WAS ADMITTED TO THE HOSPITAL AND WILL BE TAKEN BACK TO THE OR TO WASH OUT THE HEMATOMA. THE REPORTED ADVERSE EVENT (LARGE WOUND HEMATOMA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MODERATE IN SEVERITY; THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS NOT RECOVERED/NOT RESOLVED. THE REPORTED AE MEETS THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND DOES NOT MEET THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).