BEUDAMED
    FDA Adverse Event Death Summary report: N

    SLEEPTIGHT MATTRESS COVER

    MDR report key: 952642 · Received November 26, 2007

    Report

    Report Number
    2243193-2007-00001
    Event Type
    Death
    Date Received
    November 26, 2007
    Date of Event
    October 29, 2007
    Report Date
    November 16, 2007
    Manufacturer
    NATIONAL ALLERGY SUPPLY
    Product Code
    FMW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR RECEIVED A CALL FROM POLICE INDICATING A CHILD ZIPPED HIMSELF INSIDE A MATTRESS COVER AND FOUND UNCONSCIOUS. THE CHILD LATER DIED AND THE POLICE INVESTIGATION HAS DEEMED THIS A TRAGIC ACCIDENT. THERE WAS NO MALFUNCTION OF THE PRODUCT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEPTIGHT MATTRESS COVER MATTRESS COVER FMW NATIONAL ALLERGY SUPPLY TWIN SIZE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Death