BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILY ACTIVITY ASSIST DEVICE - UTENSIL FOR DRESSING, GROOMING, RECREAT

    MDR report key: 2123108 · Received June 9, 2011

    Report

    Report Number
    1525712-2011-00249
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 9, 2011
    Manufacturer
    INVACARE
    Product Code
    FNG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALLEGED HEMATOMA TO THE CONSUMER'S HEAD. MODEL AND SERIAL NUMBER OF LIFT AND SLING ARE UNKNOWN. MANUFACTURER OF SLING AND LIFT ARE UNKNOWN. AGE AND MAINTENANCE HISTORY ARE UNKNOWN. PRODUCT HAS NOT BEEN RETURNED FOR AN EVALUATION SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. MDR FILED BASED ON ALLEGED INJURY.

    Description of Event or Problem · 1

    THE CONSUMER WAS BEING LIFTED FROM A SHOWER CHAIR TO THE BED. THE LIFT WAS IN THE UP POSITION WHEN THE LOOPS FOR THE SLING ALLEGEDLY BROKE, CAUSING THE CONSUMER TO FALL AND HIT HER HEAD ON THE BASE OF THE LIFT. NO SERIOUS INJURY IS ALLEGED. NO MODEL NUMBER OR SERIAL NUMBER INFORMATION HAS BEEN GIVEN FOR THE LIFT OR SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICE - UTENSIL FOR DRESSING, GROOMING, RECREAT 890.5050 FNG INVACARE UNKNOWN SLING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Required Intervention