BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 3000

    MDR report key: 2190143 · Received May 27, 2008

    Report

    Report Number
    3004468271-2008-00008
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    December 30, 2007
    Report Date
    May 22, 2008
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTS DURING TRANSPORT FROM THE BED TO THE BATHROOM, THE RESIDENT WAS HOLDING THE HAND GRIP OF THE LIFT AND TOLD THE CNA THAT HER ARM POPPED. APPROXIMATELY TEN MINUTES LATER, THE RESIDENT STATED HER ARM WAS IN PAIN. THE RESIDENT WAS DIAGNOSED WITH A FRACTURED UPPER LEFT ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 STANDING AND RAISING AID FSA MEDIBO N.V. HEAXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention