PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT DEVELOPED SEPSIS POST IMPLANT OF A BD/BARD PHASIX MESH AND A NON-BD/BARD BIOLOGIC PORCINE DERMIS MESH, REQUIRING MESH EXPLANT. THE CAUSE OF THE SEPSIS WAS NOT REPORTED HOWEVER, THE HEALTH PROFESSIONAL REPORTING THE INCIDENT STATES THAT THE SEPSIS WAS NOT CAUSED BY THE MESH USED TO TREAT THE PATIENT. A REVIEW OF MANUFACTURING RECORDS SHOWS PRODUCT WAS MADE 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

IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT WAS IMPLANTED WITH A BD/BARD PHASIX MESH AND A NON-BD/BARD EGIS BIOLOGIC, PORCINE DERMIS. REPORTEDLY, IN THE DAYS THAT FOLLOWED, THE PATIENT WENT SEPTIC AND WAS ADMITTED TO ITU. IT WAS REPORTED THAT THE MESH WAS EXPLANTED SOMETIME BETWEEN (B)(6) THE EXACT DATE WAS NOT KNOWN. PATIENT IS NOW OUT OF ITU BUT STILL IN HOSPITAL. CONTACT REPORTS THAT HE DOESN'T BLAME THE PRODUCT FOR THE ISSUES AND DID NOT WANT TO MAKE A FORMAL COMPLAINT. THE REPORTER STATES THE MESH WAS NOT THE CAUSE OF THE SEPSIS. HOWEVER, AS THIS POSTOPERATIVE COMPLICATION REQUIRED ADDITIONAL MEDICAL SURGICAL INTERVENTION DURING WHICH THE PHASIX MESH WAS EXPLANTED WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.