BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD MESH

    MDR report key: 11854976 · Received May 19, 2021

    Report

    Report Number
    MW5101446
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    May 17, 2021
    Report Date
    May 18, 2021
    Manufacturer
    DAVOL INC., SUB. C. R. BARD, INC.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A SCHEDULED PROCEDURE, THE SURGEON ATTEMPTED TO INSERT THE BARD MESH AND THE MESH TORE APART. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742859 BARD MESH MESH, SURGICAL, POLYMERIC FTL DAVOL INC., SUB. C. R. BARD, INC. 0115322 HUDQ0602

    Patients

    Seq Age Sex Outcome Treatment
    1