BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVACARE SEATING & POSITIONING PRODUCTS

    MDR report key: 473150 · Received July 21, 2003

    Report

    Report Number
    1525712-2003-00083
    Event Type
    Other
    Date Received
    July 21, 2003
    Date of Event
    July 10, 2003
    Report Date
    July 21, 2003
    Manufacturer
    INVACARE CORPORATION - MANUFACTURING FACILITY
    Product Code
    KNN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    CONSUMER STARTED USING AN INFINITY GEL CUSHION MID-MARCH AND HAS ALLEGEDLY SINCE DEVELOPED STAGE II SKIN BREAKDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE SEATING & POSITIONING PRODUCTS 890.3920 KNN INVACARE CORPORATION - MANUFACTURING FACILITY IGCFG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other