BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREG POST OP SHOE

    MDR report key: 3203218 · Received July 2, 2013

    Report

    Report Number
    2028253-2013-00009
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BREG, INC.
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BREG CUSTOMER SERVICE AND REPORTED PRODUCT NUMBER 11192 POST OP SHOE S WITH THE SOLE SEPARATING FROM THE SHOE. NO PATIENT INJURY WAS REPORTED OR ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302724 BREG POST OP SHOE POST OP SHOE IQI BREG, INC. 11192

    Patients

    Seq Age Sex Outcome Treatment
    1