BEUDAMED
    FDA Adverse Event Death Summary report: N

    BAR,BED ASSIST

    MDR report key: 19299584 · Received May 13, 2024

    Report

    Report Number
    1417592-2024-00598
    Event Type
    Death
    Date Received
    May 13, 2024
    Date of Event
    July 30, 2020
    Report Date
    May 13, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    QTC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CONTACT ON (B)(6) 2020 THE USER OF THE BED RAIL "HAD AN UNWITNESSED FALL AND BECAME TRAPPED BETWEEN HER BED ASSIST BAR AND HER MATTRESS". PER THE CONTACT THE EVENT OCCURRED AS THE USER "WAS GETTING UP TO USE THE RESTROOM AND WAS DISCOVERED BY ASSISTED LIVING STAFF WITH HER HEAD STUCK BETWEEN THE GRAB BAR AND THE BED". PER THE CONTACT THE USER "SUFFERED BRUISING TO HER LEFT ARM FROM HER SHOULDER DOWN TO HER HAND AS A RESULT OF THE INCIDENT. PER THE CONTACT THE USER "WAS HOSPITALIZED FOR FOUR DAYS BEFORE RETURNING TO THE ASSISTED LIVING FACILITY UNTIL SHE DIED ON (B)(6) 2020". PER THE MEDICAL EXAMINER'S OFFICE "THE BROKEN RIBS ARE A RESULT OF THE CANCER AND DISEASE PROCESS AND NOT FROM THE ENTRAPMENT". THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CONTACT ON (B)(6) 2020 THE USER OF THE BED RAIL "HAD AN UNWITNESSED FALL AND BECAME TRAPPED BETWEEN HER BED ASSIST BAR AND HER MATTRESS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842307 BAR,BED ASSIST QTC MEDLINE INDUSTRIES LP

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Female Death| O