BEUDAMED
    FDA Adverse Event Summary report: N

    WALKING BOOT, BRACE

    MDR report key: 3193416 · Received June 26, 2013

    Report

    Report Number
    MW5030659
    Date Received
    June 26, 2013
    Date of Event
    April 30, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BLEDSOE COMPANY
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED HE HAD AN ANKLE SURGERY ON (B)(6), TWO WEEKS LATER HE WAS PLACED ON THE BLEDSOE ADJUST A FEET WALKING BOOT. SINCE THEN HE HAD NUMEROUS PROBLEM WITH THE VELCRO AS IT WILL STAY IN PLACE. HE ALSO HAD A PROBLEM WITH THE HEEL OF THE BOOT. THE SOLE/HEEL WILL NOT STAY IN PLACE AS IT FALL OFF DUE TO THE GLUE STICKING. CALLED THE MANUFACTURER, WAS SENT A REPLACEMENT BUT THEY ARE ALL THE SAME, THE DEVICE IS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289521 WALKING BOOT, BRACE IQI BLEDSOE COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention