BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEN BARR SAFETY MATTRESS

    MDR report key: 766161 · Received September 28, 2006

    Report

    Report Number
    MW1040534
    Event Type
    Death
    Date Received
    September 28, 2006
    Date of Event
    May 8, 2004
    Report Date
    September 28, 2006
    Manufacturer
    STEN & BARR MEDICAL
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NURSING HOME RESIDENT SLIPPED BETWEEN STEN BARR SAFETY AIR MATTRESS AND AMFAB 5700 RAILS AND DIED OF POSITIONAL ASPHYXIA PER MEDICAL EXAMINER AFTER AUTOPSY AND EVENT REVIEW. STEN BARR AND AMFAB AND NH ALL AWARE OF FDA ADVERSE EVENT REPORTING REGS BUT ELECTED TO NOT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEN BARR SAFETY MATTRESS LOW AIR LOSS MATTRESS FNM STEN & BARR MEDICAL SB 3000 SAFETY *
    2 AMFAB 5700 SIDERAIL * FNJ AMFAB AMFAB 5700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death