BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOERNS HEALTHCARE

    MDR report key: 2428318 · Received January 19, 2012

    Report

    Report Number
    MW5023926
    Event Type
    Injury
    Date Received
    January 19, 2012
    Date of Event
    January 17, 2012
    Report Date
    January 19, 2012
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EXTENSION KIT THAT ANCHORS THE ASSIST RAIL TO THE BED GAVE WAY AND CAME OFF THE BED. THE METAL CLAMP JOINT IS BENDING AND GIVING WAY ALLOWING THE EXTENSION KIT TO LIFT OFF THE FRAME AND BREAK FREE OF THE BED. THE DETENT PIN IS NOT ON ANCHOR. THIS BED HAS ONLY BEEN IN USE 6 WEEKS. THE AID CAUGHT THE PT AS HE STARTED TO FALL SO HE ONLY HIT HIS HEAD ON THE IV POLE AND SUFFERED 2 RED MARKS ON HIS FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOERNS HEALTHCARE EASY CARE BED FRAME #9 FNL JOERNS HEALTHCARE #9

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention