BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREG POST-OP SHOE

    MDR report key: 3011099 · Received March 19, 2013

    Report

    Report Number
    2028253-2013-00005
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BREG, INC.
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT A BREG POST-OP SHOE SOLE FELL OFF THE SHOE AFTER BEING USED FOR APPROXIMATELY 1 WEEK. THERE WAS NO INJURY REPORTED AND NO INFORMATION REGARDING THE PATIENT/USER. THE DEVICE WAS RETURNED TO BREG FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113168 BREG POST-OP SHOE POST-OP SHOE IQI BREG, INC. 11192

    Patients

    Seq Age Sex Outcome Treatment
    1