BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2920624 · Received December 14, 2012

    Report

    Report Number
    2025917-2012-00006
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Product Code
    BZA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN VIEW OF THE FACT THAT THE ORIGINAL FAILED DEVICE WAS NOT RETURNED, AND NO LOT NUMBER WAS PROVIDED, WE COULD NOT PERFORM A DEVICE EVAL FOR THIS PARTICULAR PRODUCTION LOT. THE FAILURE DESCRIBED IS FROM THE SUPPORT BAR ON ONE SIDE OF THE NEOBAR TEARING AWAY FROM THE MESH PORTION OF THE TAB. IN 2012 NEOTECH PRODUCTS, INC. HAS MADE A CHANGE TO MANUFACTURING PROCEDURE FOR ALL NEOBARS IN THAT THE SUPPORT BARS ARE TO BE ATTACHED TO THE LABS VIA SONIC WELDING. TESTS HAVE INDICATED SIGNIFICANTLY IMPROVED ADHESION OF THE TAB TO THE SUPPORT BAR.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE BZA

    Patients

    Seq Age Sex Outcome Treatment
    1