BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3815724 · Received May 7, 2014

    Report

    Report Number
    3815724
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    March 18, 2014
    Report Date
    May 6, 2014
    Manufacturer
    UNK
    Product Code
    ITQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS ADMITTED TO CENTER WITH A NECROTIC AREA ON HER RIGHT CALF UNDER THE KNEE IMMOBILIZER WITHOUT A TREATMENT. THEREFORE, WHEN KNEE IMMOBILIZER REMOVED, PATIENT NOTED TO HAVE STAGE IV PRESSURE AREA ON RIGHT CALF. THE IMMOBILIZER WAS REMOVED BY THE DOCTOR'S OFFICE AND DISCARDED(?), THEREFORE USER FACILITY HAS NO INFORMATION REGARDING THE KNEE IMMOBILIZER MANUFACTURER, MODEL, SN, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276733 UNKNOWN UNKNOWN ITQ UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR