BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREG POST OP SHOE

    MDR report key: 3203158 · Received July 2, 2013

    Report

    Report Number
    2028253-2013-00011
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 30, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BREG, INC.
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DISTRIBUTOR CONTACTED BREG, TWO POST OP SHOES, ITEM # 11182) HAD SEPARATED FROM THE SOLE. NO PATIENT INJURY WAS REPORTED OR ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302866 BREG POST OP SHOE POST OP SHOE IQI BREG, INC. 11182

    Patients

    Seq Age Sex Outcome Treatment
    1