BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHASIX MESH

    MDR report key: 22560169 · Received July 21, 2025

    Report

    Report Number
    1213643-2025-00661
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 7, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    OOD
    UDI-DI
    00801741137273
    PMA / PMN Number
    K161424
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2731213 PHASIX MESH SURGICAL MESH OOD DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUJX0560 00801741137273

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention