BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIDE RAIL, HALF-LENGTH-PCP-CHAMPION

    MDR report key: 57228 · Received December 17, 1996

    Report

    Report Number
    1523547-1996-90001
    Event Type
    Death
    Date Received
    December 17, 1996
    Date of Event
    November 23, 1996
    Manufacturer
    PCP-CHAMPION
    Product Code
    FNL
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS IN REF TO AN INCIDENT INVOLVING A DEATH ON 11/23/96. CO HAS SPOKEN TO THE ADMINISTRATOR AT THE FACILITY WHERE THE DEATH OCCURRED AND HE ADVISED THAT THERE WAS NO DEFECTS OR DEFAULTS IN THE RAIL AND THIS WAS NOT THE CAUSE OF DEATH. HOWEVER, CO HAS REQUESTED THAT THE RAIL BE RETURNED FOR CO'S REVIEW WHICH THE ADMINISTRATOR HAS AGREED TO DO. ONCE CO RECEIVES THE RAIL BACK AND HAS REVIEWED IT, CO WILL BE ABLE TO DO A COMPLETE FOLLOW-UP ON THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIDE RAIL, HALF-LENGTH-PCP-CHAMPION SIDE RAIL, HALF-LENGTH FNL PCP-CHAMPION 6083 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *