BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIDE RAIL

    MDR report key: 278743 · Received May 18, 2000

    Report

    Report Number
    2182305-2000-00008
    Event Type
    Other
    Date Received
    May 18, 2000
    Date of Event
    March 21, 2000
    Report Date
    April 17, 2000
    Manufacturer
    SUNRISE MEDICAL CCG
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A PT LOST BALANCE AND FELL ONTO THE SIDERAIL POST. THE POST AND CAP IMPALED INTO THE PT'S ARM AND WENT IN APPROX 8" ON AN ANGLE. PT WAS TAKEN TO THE HOSP. RAIL REMOVED. SUTURES WERE REQUIRED AND THERAPY FOR MOVEMENT. PT WAS OBSERVED FOR ANY INFECTION. AS OF THIS WRITING, NO RESPONSE OR FURTHER UPDATE HAS BEEN PROVIDED FROM FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIDE RAIL SAFETY SIDE RAIL FNJ SUNRISE MEDICAL CCG F175 FULL LENGTH RAIL *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization