BEUDAMED
    FDA Adverse Event Other Summary report: N

    SKIL-CARE

    MDR report key: 1321436 · Received February 9, 2009

    Report

    Report Number
    2431497-2009-00001
    Event Type
    Other
    Date Received
    February 9, 2009
    Date of Event
    February 8, 2009
    Report Date
    February 9, 2009
    Manufacturer
    SKIL-CARE CORP.
    Product Code
    KNN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) WOMAN SAT ON A GEL-FOAM CUSHION WHICH HAD BEEN NEXT TO A ROOM HEATER ON A WALL ALL NIGHT. SHE SAT ON THE CUSHION APPROX 30-45 MINS AND DEVELOPED A RASH LIKE A SUNBURN. SHE WAS TAKEN TO A HOSP AND TREATED WITH AN OINTMENT AND RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKIL-CARE GEL-FOAM WHEELCHAIR CUSHION KNN SKIL-CARE CORP. 751011

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization