BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEDSOE WALKING BOOT

    MDR report key: 371957 · Received January 11, 2002

    Report

    Report Number
    MW1023840
    Event Type
    Malfunction
    Date Received
    January 11, 2002
    Date of Event
    December 28, 2001
    Report Date
    January 11, 2002
    Manufacturer
    MEDICAL TECHNOLOGIES INC
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDICAL TECHNOLOGIES INC BLEDSOE WALKING BOOT SOLE FAILURE. PT WAS WARNED THAT THE SOLE COULD FAIL BY THE PROSTHETICS TECHS BECAUSE SEVERAL RECENTLY HAD. IT FAILED WITHIN 5 HRS OF LIGHT DUTY USE. ON EXAMINATION, IT WAS OBVIOUS THAT INSUFFICIENT GLUE WAS APPLIED AND IT WAS NOT CLAMPED WITH SUFFICIENT PRESSURE. ALSO THE ALIGNMENT TABS ON THE SOLE WERE GROSSLY DEFICIENT AND NO QA HAD BEEN DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLEDSOE WALKING BOOT SPLINT IQI MEDICAL TECHNOLOGIES INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other