BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEXAS MEDICAL INDUSTRIES

    MDR report key: 2547846 · Received April 19, 2012

    Report

    Report Number
    MW5025152
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Date of Event
    April 9, 2012
    Report Date
    April 19, 2012
    Manufacturer
    TMI
    Product Code
    ILZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS USING TRAPEZE BAN TO PULL HERSELF UP IN BED AFTER SURGERY. THE CHAIN SEPARATED AND BROKE FREE FROM SYSTEM CAUSING BAN TO COME LOOSE. NURSE CAUGHT BAR, NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEXAS MEDICAL INDUSTRIES TRAPEZE ASSEMBLY (BAR) ILZ TMI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other