PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT UNDERWENT A PROCEDURE TO TREAT AN INFECTION AND CHRONIC DRAINING SINUS. THE ABDOMEN WAS CLOSED AFTER ADDRESSING THE INFECTION AND CHRONIC DRAINING SINUS AND A PHASIX MESH WAS PLACED AS AN ONLAY. ABOUT 5 MONTHS POST IMPLANT THE PATIENT PRESENTED WITH A RECURRENCE OF THE INFECTION AND DRAINING SINUS AND UNDERWENT RE-OPERATION. THE SURGEON REPORTS HE FOUND THAT THE PHASIX MESH OVER THE MIDLINE HAD SEEMED TO HAVE AN ENCAPSULATED RESPONSE, WAS NOT INCORPORATED, AND WAS WRINKLED IN THE AREA. NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S POSTOPERATIVE COURSE. HOWEVER, THE USE OF THE PHASIX MESH IN A COMPROMISED ENVIRONMENT MAY HAVE CONTRIBUTED TO THE ISSUES THAT PRESENTED. THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE, STATES, "THE USE OF ANY MESH OR PATCH IN A CONTAMINATED OR INFECTED WOUND CAN LEAD TO FISTULA FORMATION AND/OR EXTRUSION OF THE MESH." AND "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." NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (12-SEP-2025) IS CONSIDERED TO BE A BEST ESTIMATE 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.

Description of Event or Problem

AS REPORTED, PATIENT EXPERIENCED CHRONIC DRAINING SINUS AND INFECTION ABOUT 5 MONTHS AGO. AFTER ADDRESSING THE INFECTION AND SINUS ISSUE, THE SURGEON IMPLANTED A PHASIX MESH AS AN ONLAY. PER INFORMATION REPORTED, THE PATIENT HAD RECURRENCE OF THE SINUS DRAIN AND INFECTION. THE SURGEON OPERATED AND FOUND THAT THE PHASIX MESH OVER THE MIDLINE SEEMED TO HAVE ENCAPSULATED, WAS NOT INCORPORATED, AND WAS WRINKLED AT THE AREA. THE UNINCORPORATED PHASIX MESH WAS REMOVED AND THE ABDOMEN WAS CLOSED PRIMARILY.

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT UNDERWENT A PROCEDURE TO TREAT AN INFECTION AND CHRONIC DRAINING SINUS. THE ABDOMEN WAS CLOSED AFTER ADDRESSING THE INFECTION AND CHRONIC DRAINING SINUS AND A PHASIX MESH WAS PLACED AS AN ONLAY. ABOUT 5 MONTHS POST IMPLANT THE PATIENT PRESENTED WITH A RECURRENCE OF THE INFECTION AND DRAINING SINUS AND UNDERWENT RE-OPERATION. THE SURGEON REPORTS HE FOUND THAT THE PHASIX MESH OVER THE MIDLINE HAD SEEMED TO HAVE AN ENCAPSULATED RESPONSE, WAS NOT INCORPORATED, AND WAS WRINKLED IN THE AREA. NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S POSTOPERATIVE COURSE. HOWEVER, THE USE OF THE PHASIX MESH IN A COMPROMISED ENVIRONMENT MAY HAVE CONTRIBUTED TO THE ISSUES THAT PRESENTED. THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE, STATES, "THE USE OF ANY MESH OR PATCH IN A CONTAMINATED OR INFECTED WOUND CAN LEAD TO FISTULA FORMATION AND/OR EXTRUSION OF THE MESH." AND "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." ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE PMA/510(K). A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO THE SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF 125 UNITS RELEASED FOR DISTRIBUTION. UPDATED FIELDS: B3, B4, B.5, D4 (PRODUCT CATALOG NO., CORPORATE LOT NO., EXPIRY DATE, UDI NO.), D6A, D6B, G3, G6, H2, H4, H6, H10, H11. CORRECTED FIELD: G4 (PMA/510(K)) 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, PATIENT EXPERIENCED CHRONIC DRAINING SINUS AND INFECTION ABOUT 5 MONTHS AGO. AFTER ADDRESSING THE INFECTION AND SINUS ISSUE, THE SURGEON IMPLANTED A PHASIX MESH AS AN ONLAY. PER INFORMATION REPORTED, THE PATIENT HAD RECURRENCE OF THE SINUS DRAIN AND INFECTION. THE SURGEON OPERATED AND FOUND THAT THE PHASIX MESH OVER THE MIDLINE SEEMED TO HAVE ENCAPSULATED, WAS NOT INCORPORATED, AND WAS WRINKLED AT THE AREA. THE UNINCORPORATED PHASIX MESH WAS REMOVED AND THE ABDOMEN WAS CLOSED PRIMARILY. ADDENDUM: AS REPORTED, PATIENT WAS IMPLANTED WITH PHASIX MESH ON (B)(6) 2025 AND THE PARTIAL EXPLANATION OF THE MESH WAS PERFORMED ON (B)(6) 2025.