BEUDAMED
    FDA Adverse Event Death Summary report: N

    DALTON

    MDR report key: 1642673 · Received March 17, 2010

    Report

    Report Number
    1640826-2010-00001
    Event Type
    Death
    Date Received
    March 17, 2010
    Date of Event
    October 13, 2009
    Report Date
    March 16, 2010
    Manufacturer
    KENSTON HOLDING CORP.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: IT IS MY OPINION THAT (B)(6), AN (B)(6) FEMALE, DIED AS A RESULT OF MECHANICAL COMPRESSION. IT IS MY FURTHER OPINION THAT HER HYPERTENSIVE AND ATHEROSCLEROTIC CARDIOVASCULAR DISEASE CONTRIBUTED TO HER DEATH.

    Description of Event or Problem · 1

    HOSPICE PT DIED AS A RESULT OF MECHANICAL COMPRESSION DUE TO IMPROPER INSTALLATION OF FULL LENGTH BED RAIL BY (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DALTON FULL LENGTH BED RAIL FNL KENSTON HOLDING CORP. B-T200

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death