BEUDAMED
    FDA Adverse Event Death Summary report: N

    REDUCE GAP HALF LGT BED RAILS 9153601866

    MDR report key: 5535466 · Received March 30, 2016

    Report

    Report Number
    1525712-2016-00914
    Event Type
    Death
    Date Received
    March 30, 2016
    Report Date
    March 21, 2016
    Manufacturer
    UNKNOWN
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    SUBPOENA SENT STATING: THE END USER WAS A PATIENT AT A RESIDENCE CARE FACILITY, (B)(6) WHERE SHE PASSED AWAY FROM STRANGULATION POTENTIALLY FROM THE SIDE RAILS THAT WERE ON HER BED. ACCORDING TO ATTORNEY, THE QUESTION STILL REMAINS AS TO IF THE DECEDENT PASSED DUE TO NATURAL CAUSES AND ROLLED INTO THE RAIL THE WAY THEY FOUND HER OR IF THE RAILS ACTUALLY WERE PART OF THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190455 REDUCE GAP HALF LGT BED RAILS 9153601866 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL UNKNOWN 6630

    Patients

    Seq Age Sex Outcome Treatment
    1