BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIO GUARD PLUS MATTRESS

    MDR report key: 80225 · Received March 27, 1997

    Report

    Report Number
    1034630-1997-00001
    Event Type
    Death
    Date Received
    March 27, 1997
    Date of Event
    January 20, 1997
    Report Date
    January 31, 1997
    Manufacturer
    BIO CLINIC
    Product Code
    FNM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT, WAS ORDERED UNDER "PROGRESSIVE RESTRAINT" BY ATTENDING PHYSICIAN. PT APPARENTLY OBTAINED A BUTANE LIGHTER PRIOR TO BEING RESTRAINED IN BED. HE WAS RESTRAINED BY LEATHER STRAPS ON THE LEFT WRIST AND RIGHT ANKLE. HE WAS OBSERVED, PRIOR TO FIRE, BY A PT ACROSS HALL TRYING TO BURN WRIST RESTRAINT STRAP AND INADVERTENTLY SET PILLOW AND LINENS ON FIRE. PT DIED AND HIS ROOMATE DIED FROM SMOKE INHALATION. CA 117 DEFINES THE PERFORMANCE OF MATERIALS USED IN MATTRESSES DESCRIBED AS "FIRE RETARDANT". WHILE THE MATTRESS MAY BE BURNED WHILE SUBJECT TO A FLAME IT WILL SELF-EXTINGUISH WHEN THE FLAME SOURCE IS REMOVED, MATTRESS APPEARED TO HAVE PERFORMED IN THIS MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO GUARD PLUS MATTRESS MATTRESS FNM BIO CLINIC 10600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death