BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFE - T - MATE

    MDR report key: 2803246 · Received October 17, 2007

    Report

    Report Number
    2803246
    Event Type
    Injury
    Date Received
    October 17, 2007
    Date of Event
    September 27, 2007
    Report Date
    October 9, 2007
    Manufacturer
    210 INNOVATIONS LLC
    Product Code
    KNN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT STOOD UP FROM WHEELCHAIR, AUTO-LOCKS DID NOT STOP WC ET CHAIR ROLLED BACKWARD. PT FELL AND FRACTURED NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFE - T - MATE ANTI-ROLL BACK DEVICE KNN 210 INNOVATIONS LLC SM2-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention