BEUDAMED
    FDA Adverse Event Death Summary report: N

    DBD-BAR,BED ASSIST

    MDR report key: 20031905 · Received August 22, 2024

    Report

    Report Number
    1417592-2024-00814
    Event Type
    Death
    Date Received
    August 22, 2024
    Date of Event
    October 22, 2020
    Report Date
    August 21, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    BTR
    Removal / Correction Number
    R-24-MED 3
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER CONTACT "MY ELDERLY MOTHERS ENTIRE RIGHT ARM BECAME WEDGED BETWEEN THE RAIL AND THE MATTRESS, CLOSE TO THE BOX SPRING". PER THE CONTACT THE USER OF THE DEVICE BECAME ENTRAPPED AND EXPIRED "WITH HER FACE BURIED IN BLANKETS WADDED UP AT THE SIDE OF THE MATTRESS WHERE SHE HAD FALLEN". PER THE CONTACT "HER ARM WAS TRAPPED ALL THE WAY UP TO HER SHOULDER" AND SHE WAS FOUND DECEASED "WITH HER FACE STUFFED IN BEDDING WHERE THE RAIL MET THE BED". PER THE CONTACT THEY WERE NOT ABLE TO CONFIRM IF THE SECUREMENT STRAP WAS USED. THE DEVICE 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 CUSTOMER CONTACT "MY ELDERLY MOTHERS ENTIRE RIGHT ARM BECAME WEDGED BETWEEN THE RAIL AND THE MATTRESS, CLOSE TO THE BOX SPRING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218034 DBD-BAR,BED ASSIST BTR MEDLINE INDUSTRIES LP

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Death