BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODY ARMOR WALKER HI

    MDR report key: 356503 · Received October 17, 2001

    Report

    Report Number
    MW1023133
    Event Type
    Malfunction
    Date Received
    October 17, 2001
    Date of Event
    October 11, 2001
    Report Date
    October 17, 2001
    Manufacturer
    DARCO INT'L, INC.
    Product Code
    IPG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT DIAGNOSED WITH TEAR IN ACHILLES TENDON. THE PT RECEIVED A BOOT CAST AT DR'S OFFICE. NINE DAYS LATER, THE BOOT CAST BROKE WHILE THE PT WAS WEARING IT. THE PLASTIC BROKE AT THE ANKLE BUCKLE ON THE RIGHT SIDE OF THE BOOT. ON THE LEFT SIDE, THE LEG SUPPORT SEPARATED FROM THE FOOT SUPPORT. THE BUCKLE AT THE ANKLE WOULD NOT STAY CLOSED. THE PT WAS SITTING IN A CHAIR AND MOVING FOOT WHEN THE BOOT CAST BROKE. PRIOR TO THIS, THERE WAS NO PHYSICAL DAMAGE TO THE BOOT CAST. THE PT RETURNED THE BOOT CAST TO DR FIVE DAYS LATER. THE DR'S STAFF SAID THE BOOT CAST WOULD BE RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46540 BODY ARMOR WALKER HI BOOT CAST IPG DARCO INT'L, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other