BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG BEDRAILS

    MDR report key: 95215 · Received June 3, 1997

    Report

    Report Number
    MW1011389
    Event Type
    Malfunction
    Date Received
    June 3, 1997
    Date of Event
    April 28, 1997
    Report Date
    May 20, 1997
    Manufacturer
    RED LINE HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT FOUND WITH LEFT FOOT WEDGED IN BEDRAIL MECHANISM. RPTR HAS NO WAY OF KNOWING IF PRODUCT INFO IS CORRECT AS THESE BEDRAILS HAVE BEEN IN USE 10 PLUS YEARS - INFO WAS PULLED FROM A 1993 ORDER WHICH "LOOKS" IDENTICAL TO THE OLDER BEDRAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG BEDRAILS LONG BEDRAILS FNL RED LINE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other