BEUDAMED
    FDA Adverse Event Death Summary report: N

    DALTON

    MDR report key: 1635304 · Received March 16, 2010

    Report

    Report Number
    1649595-2010-00001
    Event Type
    Death
    Date Received
    March 16, 2010
    Date of Event
    October 13, 2009
    Report Date
    March 16, 2009
    Manufacturer
    KENSTONE HOLDING CORP.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS MY OPINION THAT (B)(4), 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

    THE (B)(6) PATIENT DIED AND CAUSED FROM IMPROPER INSTALLATION OF FULL LENGTH BED RAILS BY THE COMPANY - MED DEPT AND RESULTED WITH "MECHANICAL COMPRESSION". FOR ZONE 6 ENTRAPMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death