BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREG POST-OP SHOE

    MDR report key: 3784753 · Received May 1, 2014

    Report

    Report Number
    2028253-2014-00011
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BREG, INC.
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT ARRIVED FOR INVESTIGATION. THIS IS A KNOWN FAILURE MODE. THE SUPPLIER OF THE POST-OP SHOE HAS BEEN ISSUED A CORRECTIVE ACTION AND HAS BEEN UNABLE TO DETERMINE THE ROOT CAUSE OF THE FAILURE. BREG IS NO LONGER DISTRIBUTING THIS PRODUCT.

    Description of Event or Problem · 1

    REPORT THE SOLE SEPARATING FROM THE SHOE ON A POST OP SHOE AFTER 2 WEEKS. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261442 BREG POST-OP SHOE POST-OP SHOE IQI BREG, INC. 11194

    Patients

    Seq Age Sex Outcome Treatment
    1