BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREG POST-OP SHOE

    MDR report key: 3232468 · Received July 18, 2013

    Report

    Report Number
    2028253-2013-00012
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    July 17, 2013
    Manufacturer
    BREG, INC.
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BREG CUSTOMER SERVICE AND REPORTED THAT A POST OP SHOE, WOMENS, MEDIUM (ITEM (B)(4)), SEPARATED FROM SOLE AFTER BEING WORN FOR ONE WEEK. PRODUCT IS AWAITING RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335897 BREG POST-OP SHOE POST-OP SHOE IQI BREG, INC. 11183

    Patients

    Seq Age Sex Outcome Treatment
    1