BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIDE RAILS

    MDR report key: 278763 · Received May 18, 2000

    Report

    Report Number
    2182305-2000-00009
    Event Type
    Death
    Date Received
    May 18, 2000
    Date of Event
    April 15, 2000
    Report Date
    May 4, 2000
    Manufacturer
    SUNRISE MEDICAL CCG
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITIES ADMINISTRATOR OF AN ENTRAPMENT DEATH,THAT FACILITY REQUESTED ALL PRODUCT SAFETY LITERATURE. WHEN THE ADMINISTRATOR BEGAN TO INQUIRE ON DETAILS OF ALLEGED INCIDENT, ADMINISTRATOR WAS TOLD "FACILITY REP WAS ADVISED BY COUNSEL NOT TO SAY ANYTHING". ADMINISTRATOR THEN AGAIN ASKED FOR PRODUCT SAFETY LITERATURE. NO RESPONSE FROM FACILITY AFTER SEVERAL ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIDE RAILS SAFETY SIDE RAILS FNJ SUNRISE MEDICAL CCG F1451 1/2 LENGTH SIDE RAIL *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death