BEUDAMED
    FDA Adverse Event Death Summary report: N

    GOWN, PATIENT

    MDR report key: 6004595 · Received October 6, 2016

    Report

    Report Number
    1417592-2016-00100
    Event Type
    Death
    Date Received
    October 6, 2016
    Date of Event
    August 28, 2016
    Report Date
    October 6, 2016
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    FYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PER DIRECTOR OF NURSING (DON) AT FACILITY WHO STATED ON (B)(6) NURSING STAFF FOUND A PATIENT DECEASED WITH PATIENT GOWN STRINGS CAUGHT IN SIDE RAIL OF BED. PER DON PATIENT WAS RESIDENT OF THE NURSING HOME DUE TO MULTIPLE CARDIAC AND RESPIRATORY ISSUES. PATIENT WAS OXYGEN DEPENDENT AND NEEDED ASSISTANCE TO GET IN AND OUT OF BED. PATIENT WOULD NOT GET OUT OF BED WITHOUT ASSISTANCE DUE TO WEAKNESS. PATIENT USED A WALKER ON A DAILY BASIS WHEN OUT OF BED. PATIENT WAS FOUND SITTING ON FLOOR; HIS BACK WAS LEANING AGAINST HIS BED WITH HIS CHIN RESTING ON HIS CHEST. THE NECK OF THE GOWN WAS CAUGHT AROUND THE RAISED EDGE OF THE SIDERAIL END CAP. GOWN STRINGS WERE TIED, ENDS OF STRINGS WERE NOT ENTANGLED ON ANY PART OF THE SIDERAIL OR BED. BED WAS IN IT'S LOWEST POSITION; HEAD OF BED ELEVATED TO AN UNKNOWN DEGREE, WITH BOTH UPPER SIDE RAILS IN THE UP POSITION. PATIENT CALL BUTTON WAS WITHIN REACH, NO BED ALARM WAS ON. PATIENT BED WAS NOT MANUFACTURED BY MEDLINE. THE AGE AND OVERALL CONDITION OF THE BED AND SIDERAIL IS UNKNOWN. A ROOT CAUSE FOR THIS INCIDENT HAS NOT BEEN DETERMINED. DUE TO THE REPORTED DEATH AND IN AN ABUNDANCE OF CAUTION THIS MEDWATCH IS BEING FILED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT FOUND ON FLOOR WITH GOWN ATTACHED TO BEDRAIL AND PRONOUNCED DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656941 GOWN, PATIENT FYB MEDLINE INDUSTRIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death