BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARE WIDE EXTENSION KIT

    MDR report key: 3955166 · Received July 16, 2014

    Report

    Report Number
    3009402404-2014-00017
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    JOERNS HEALTHCARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR BY THE FACILITY (B)(4), PER THE FACILITY, THE RESIDENT WAS ASSISTING THE STAFF IN ROLLING HERSELF OVER SO THE SHEETS COULD BE CHANGED. THE RESIDENT WAS PULLING ON THE RAIL AND THE COMFEXT CAME OFF THE BED. THE RESIDENT ROLLED OFF THE BED AND LANDED ON THE FLOOR. THE RESIDENT WAS TRANSPORTED TO THE HOSPITAL FOR X-RAYS AND SHE SUSTAINED A BROKEN CHEEK BONE. COMPLAINT # (B)(4) AND RA# (B)(4) WERE ENTERED INTO OUR SYSTEM TO RETURN THE COMFEXT TO JOERNS FOR INVESTIGATION. AS OF THIS WRITING, THE COMFEXT HAS NOT BEEN RECEIVED AT JOERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416051 CARE WIDE EXTENSION KIT BED WIDTH EXTENSION FNL JOERNS HEALTHCARE COMFEXT_KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization