BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD FLAT MESH

    MDR report key: 18493878 · Received January 11, 2024

    Report

    Report Number
    1213643-2024-00004
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 19, 2023
    Report Date
    January 2, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION PROVIDED IS LIMITED AT THIS TIME AND IT IS UNCLEAR WHAT THE CONTACT¿S ¿CURRENT HEALTH ISSUES¿ ARE OR WHY THEY ARE REQUESTING INFORMATION ON THE PRODUCT. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT ((B)(6) 2023) IS ESTIMATED BASED ON INFORMATION PROVIDED. 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. H3 OTHER TEXT : NOT RETURNED.

    Description of Event or Problem · 0

    AS REPORTED, "TRYING TO GET TECHNICAL SPEC AND IFU FOR THE MARLEX MESH FROM CR BARD FOR SOME CURRENT HEALTH ISSUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954671 BARD FLAT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other