BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINCO

    MDR report key: 1849485 · Received September 27, 2010

    Report

    Report Number
    1027229-2010-00001
    Event Type
    Injury
    Date Received
    September 27, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 22, 2010
    Manufacturer
    WINCO MFG., LLC
    Product Code
    FRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAFETY SHIELDS WERE ORDERED BY THE DISTRIBUTOR AND SENT TO THE USER FACILITY. INSTRUCTIONS FOR INSTALLATION OF THE SAFETY SHIELDS WERE ALSO SENT TO THE USER FACILITY.

    Description of Event or Problem · 1

    A MALE RESIDENT AT (B)(6) HEALTH CARE IN (B)(6) WAS IN THE CHAIR IN A RECLINED POSITION WITH HIS HANDS BY HIS SIDE. THE ATTENDANT ATTEMPTED TO RAISE THE RESIDENT, AND AS THE ATTENDANT WAS DOING THAT, THE RESIDENT PLACED HIS HANDS BETWEEN THE SEAT AND THE SIDE PANEL AND GOT HIS FINGERS CAUGHT IN THE MECHANISM. RESIDENT'S FINGERS WERE CUT, HE WAS TRANSPORTED TO THE HOSPITAL AND RECEIVED STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINCO COMFORT CARE PREMIER RECLINER FRJ WINCO MFG., LLC 5560

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization