BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREG POST-OP SHOE

    MDR report key: 5066106 · Received September 9, 2015

    Report

    Report Number
    2028253-2015-00008
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Report Date
    September 9, 2015
    Manufacturer
    BREG, INC.
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING PRODUCT RETURN. 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. AWAITING PRODUCT RETURN.

    Description of Event or Problem · 1

    SOLE SEPARATED FROM BASE OF SHOE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595148 BREG POST-OP SHOE POST-OP SHOE IQI BREG, INC. 11192

    Patients

    Seq Age Sex Outcome Treatment
    1