BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE SEATING & POSITIONING PRODUCTS

    MDR report key: 1019814 · Received March 26, 2008

    Report

    Report Number
    1525712-2008-00023
    Event Type
    Injury
    Date Received
    March 26, 2008
    Report Date
    March 24, 2008
    Manufacturer
    MOTION CONCEPTS
    Product Code
    IMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER WAS USING A CUSHION AND REPORTEDLY DEVELOPED A SORE SHORTLY AFTER. NO MODEL AND OR CUSHION SERIAL NUMBER HAS BEEN PROVIDED. MANUFACTURER ATTEMPTING TO OBTAIN CUSHION FOR INSPECTION. MDR FIELD BASED ON ALLEGED INJURY.

    Description of Event or Problem · 1

    WITHIN 3 WEEKS OF USING THE NEW CUSHION, THE CONSUMER RECEIVED A PRESSURE ULCER ON THEIR BUTTOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE SEATING & POSITIONING PRODUCTS 890.3920 IMP MOTION CONCEPTS UNKSEAT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention