BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE .T. MATE

    MDR report key: 2704724 · Received April 30, 2007

    Report

    Report Number
    2704724
    Event Type
    Malfunction
    Date Received
    April 30, 2007
    Date of Event
    April 14, 2007
    Report Date
    April 16, 2007
    Manufacturer
    210 INNOVATIONS LLC
    Product Code
    KNN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RESIDENT LEANED FORWARD IN WHEEL CHAIR. VELCROBELT BECAME DISCONNECTED FROM WHEEL CHAIR WHEN SCREW CAME OUT. RESIDENT FELL TO THE GROUND. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE .T. MATE ALARMED VELCRO SEATBELT KNN 210 INNOVATIONS LLC SM-005

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other