BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEL-FOAM PAD

    MDR report key: 301141 · Received October 21, 2000

    Report

    Report Number
    MW1020216
    Event Type
    Death
    Date Received
    October 21, 2000
    Date of Event
    October 13, 2000
    Report Date
    October 21, 2000
    Manufacturer
    SKIL-CARE
    Product Code
    KNN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/19/00: MFR WOULD LIKE TO ADVISE THAT THIS IS VIRTUALLY IMPOSSIBLE. THE CUSHION'S FABRIC AND VINYL HAVE BOTH MET CALIFORNIA BULLETIN 117B REQUIREMENTS. (TEST RESULTS ARE AVAILABLE). IN ADDITION, THE ENTIRE UPPER LAYER OF THE CUSHION IS FILLED WITH A WATER-BASED GEL WHICH IS NOT FLAMMABLE.

    Description of Event or Problem · 1

    THE "GEL-FOAM PAD" WAS IGNITED AND MOST LIKELY CAUSED THE WHEELCHAIR'S SEAT AND SEAT BACK FABRIC TO BURN AWAY. THE BURNING OF THE "GEL-FOAM PAD" IN COMBINATION WITH THE WHEELCHAIR FABRIC CAUSED THE PT TO SUFFER FATAL 3RD DEGREE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL-FOAM PAD WHEELCHAIR CUSHION KNN SKIL-CARE 751010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death HOSP WHEELCHAIR WITH A DOUBLE LAYERED, SYNTHETIC| WHEELCHAIR MAKER'S NAME AND THE SERIAL NUMBER FROM| THE INVOLVED CHAIR IS AVAILABLE UPON REQUEST.| FABRIC BASED, SEAT BOTTOM AND SEAT BACK . THE