PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, PATIENT DEVELOPED HAEMATOSARCOMA POST IMPLANT OF PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE OF HEMATOMA, SEROMA AS POSSIBLY RELATED TO THE STUDY DEVICE WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. SEROMA AND HEMATOMA ARE CLINICALLY UNDERSTOOD POTENTIAL COMPLICATIONS OF SURGERY/USE OF THE DEVICE AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. ADDENDUM: THIS SUPPLEMENTAL MDR IS SUBMITTED TO CORRECT THE TYPE OF REPORTABLE EVENT AND ADVERSE TYPE. UPDATED FIELDS: B4, G3, G6, H2, H6, H10, H11. CORRECTED FIELDS: B1 (ADVERSE TYPE), B2 (EVENT ATTRIBUTED TO), H1 (TYPE OF REPORTABLE EVENTS). 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)(6): THE SUBJECT PATIENT UNDERWENT A LYSIS OF ADHESIONS ON (B)(6) 2024, DURING WHICH A PHASIX MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH SUTURES. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBABLE MONOFILAMENT 0 PDS SUTURES. ON (B)(6) 2025, PATIENT UNDERWENT SONOGRAPHY/ABDOMINAL WALL SHOWS HAEMATOSARCOMA NOT WORTHY OF PUNCTURE. THE REPORTED ADVERSE EVENT (HAEMATOSARCOMA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSAL RELATIONSHIP TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY, AND IT IS RECOVERING/RESOLVING. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, PATIENT DEVELOPED HAEMATOSARCOMA POST IMPLANT OF PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE OF HEMATOMA, SEROMA AS POSSIBLY RELATED TO THE STUDY DEVICE WITH A CAUSAL RELATIONSHIP TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. SEROMA AND HEMATOMA ARE CLINICALLY UNDERSTOOD POTENTIAL COMPLICATIONS OF SURGERY/USE OF THE DEVICE AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT 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 CLINICAL TRIAL (B)(4) THE SUBJECT PATIENT UNDERWENT A LYSIS OF ADHESIONS ON (B)(6) 2024, DURING WHICH A PHASIX MESH ONLAY WAS PLACED AND SECURED IN PLACE WITH SUTURES. THE SURGERY WAS DONE WITH TRIMMING THE PHASIX MESH AND THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH ETHICON SLOW ABSORBABLE MONOFILAMENT 0 PDS SUTURES. ON (B)(6) 2025, PATIENT UNDERWENT SONOGRAPHY/ABDOMINAL WALL SHOWS HAEMATOSEROMA NOT WORTHY OF PUNCTURE. THE REPORTED ADVERSE EVENT (HAEMATOSEROMA) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSAL RELATIONSHIP TO THE PROCEDURE. IT HAS BEEN ASSESSED AS MILD IN SEVERITY, AND IT IS RECOVERING/RESOLVING. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).