BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAIL,HALF SZ,CLAMP ON,SM GAP BAR SPACE

    MDR report key: 8811706 · Received July 22, 2019

    Report

    Report Number
    1417592-2019-00115
    Event Type
    Death
    Date Received
    July 22, 2019
    Date of Event
    July 10, 2019
    Report Date
    July 22, 2019
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE END-USER WAS SLEEPING WHEN HER HUSBAND CHECKED ON HER AT 0300. AT APPROXIMATELY 0500 SHE WAS FOUND ON THE FLOOR WITH HER NECK CAUGHT IN THE BED RAIL. WHEN SHE WAS FOUND, HER HUSBAND INITIATED CPR AND CALLED FOR PARAMEDICS. THE END-USER WAS DECLARED DECEASED UPON THE ARRIVAL OF PARAMEDICS. REPORTEDLY, THE SIDE RAIL WAS PLACED AT THE HEAD OF THE BED AND WAS NOT USED IN CONJUNCTION WITH OTHER SIDE RAILS. NO ADDITIONAL INFORMATION WAS REPORTED TO THE MANUFACTURER. NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. DUE TO THE REPORTED DEATH, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END-USER CAUGHT HER NECK IN THE BED RAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607919 RAIL,HALF SZ,CLAMP ON,SM GAP BAR SPACE FNL MEDLINE INDUSTRIES INC. 10819010033

    Patients

    Seq Age Sex Outcome Treatment
    1 Death