BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD VENTRALEX

    MDR report key: 2162518 · Received July 5, 2011

    Report

    Report Number
    2162518
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 5, 2011
    Manufacturer
    DAVOL, INC. / C. R. BARD, INC.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    OR STAFF REPORTS WHILE SURGEON ATTEMPTING TO PLACE THIS BARD VENTRALEX HERNIA PATCH, THE RING IN THE MIDDLE PORTION WHICH ALLOWS THE MESH DEVICE TO MAINTAIN ITS SHAPE POPPED/SNAPPED AND THE RING PORTION CRUMPLED LOSING IT'S INTEGRITY. THIS FAILURE REQUIRED THE SURGEON TO REQUEST AND PLACE A SECOND DEVICE (SAME TYPE AND MODEL). NO INJURY TO PATIENT, JUST DELAY IN OBTAINING SECOND DEVICE AND PLACING AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD VENTRALEX BARD VENTRALEX HERNIA PATCH FTL DAVOL, INC. / C. R. BARD, INC. 0010301 HUUH1440

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR