BEUDAMED
    FDA Adverse Event Summary report: N

    UNIVERSAL KNEE IMMOBILIZER

    MDR report key: 1941387 · Received December 9, 2010

    Report

    Report Number
    1941387
    Date Received
    December 9, 2010
    Date of Event
    November 26, 2010
    Report Date
    December 9, 2010
    Manufacturer
    CORFLEX
    Product Code
    IQI
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS USING THE RESTROOM WHEN THE KNEE IMMOBILIZER BENT, CAUSING THE PATIENT TO FALL TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL KNEE IMMOBILIZER ORTHOSIS, LIMB BRACE, KNEE IMMOBILIZER IQI CORFLEX * *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR