BEUDAMED
    FDA Adverse Event Death Summary report: N

    DBD-BAR,BED ASSIST

    MDR report key: 19609566 · Received June 25, 2024

    Report

    Report Number
    1417592-2024-00685
    Event Type
    Death
    Date Received
    June 25, 2024
    Date of Event
    April 19, 2021
    Report Date
    June 25, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    QTC
    Removal / Correction Number
    R-24-MED3
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER ON (B)(6) 2021 THE USER BECAME ENTRAPPED IN THE RAIL CAUSING "THE NECK TO BE COMPRESSED BETWEEN RAIL AND MATTRESS LEADING TO ASPHYXIATION". 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/DEATH THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED G6 TO 30 DAY AND UPDATED H2 TO CORRECTION.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER ON (B)(6) 2021 THE USER BECAME ENTRAPPED IN THE RAIL CAUSING "THE NECK TO BE COMPRESSED BETWEEN RAIL AND MATTRESS LEADING TO ASPHYXIATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698021 DBD-BAR,BED ASSIST QTC MEDLINE INDUSTRIES LP

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female Death