BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAILY ACTIVITY ASSIST DEVICES-UTENSIL FOR DRESSING, GROOMING RECREAT

    MDR report key: 1721469 · Received June 8, 2010

    Report

    Report Number
    1525712-2010-00079
    Event Type
    Death
    Date Received
    June 8, 2010
    Date of Event
    May 11, 2010
    Report Date
    June 9, 2010
    Manufacturer
    INVACARE
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO CAREGIVERS WERE REPORTEDLY TRANSFERRING A PATIENT AND AN ALLEGED INVACARE SLING TORE. THE LIFT INVOLVED IN THE INCIDENT IS NOT AN INVACARE LIFT. THIS RESULTED IN THE RESIDENT FALLING FROM THE SLING AND RECEIVING A LACERATION ON THEIR BACKSIDE. THE RESIDENT WAS REPORTEDLY TREATED AT THE SCENE. NO TAGS WERE VISIBLE ON THE SLING. THE DEALER INDICATED THE TAGS WERE REMOVED BY THE CONSUMER. THE USER REPORTEDLY HAS SINCE PASSED. DEVICE SERVICE AND MAINTENANCE HISTORY IS UNKNOWN. IT'S UNREPORTED IF THE DEATH IS A RESULT OF THE INCIDENT. MDR FILED AS A CONSERVATIVE MEASURE.

    Description of Event or Problem · 1

    WHILE BEING TRANSPORTED FROM HER BED TO A WHEELCHAIR BY 2 NURSES, THE HANGING CORDS ON BOTH SIDES OF THE SLING ALLEGEDLY RIPPED, CAUSING THE CONSUMER TO FALL. THE CONSUMER ALLEGEDLY SUSTAINED A LACERATION ON HER BACKSIDE AND PASSED AWAY OVER THE WEEKEND. IT IS NOT KNOWN IF THE ALLEGED INCIDENT CONTRIBUTED TO THE CONSUMER'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES-UTENSIL FOR DRESSING, GROOMING RECREAT 890.5050 FSA INVACARE R111

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death| R