BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOF.CARE

    MDR report key: 295762 · Received August 29, 2000

    Report

    Report Number
    1313850-2000-00001
    Event Type
    Death
    Date Received
    August 29, 2000
    Date of Event
    January 5, 1999
    Report Date
    August 7, 2000
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT FOUND WITH HEAD WEDGED BETWEEN THE END OF THE HALF SIDE RAIL AND THE MATTRESS. THERE WAS NO FAILURE OF THE SIDE RAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOF.CARE MATTRESS OVERLAY FNM GAYMAR INDUSTRIES, INC. SC427 OVERLAY CP300 PUMP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death