BEUDAMED
    FDA Adverse Event Other Summary report: N

    MRAIL

    MDR report key: 391567 · Received April 29, 2002

    Report

    Report Number
    MW1024847
    Event Type
    Other
    Date Received
    April 29, 2002
    Date of Event
    April 25, 2002
    Report Date
    April 29, 2002
    Manufacturer
    ALIMED
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D 6/11/02: PLEASE NOTE THAT ALIMED IS NOT THE MFR OF THE M RAIL, ASSISTIVE BED RAIL. THEY PURCHASED THAT PRODUCT FROM: LCM DISTRIBUTION LTD. CO HAS FORWARDED THE PAPERWORK SENT TO LCM.

    Description of Event or Problem · 1

    RESIDENT WAS FOUND NOT BREATHING, LYING ON A MAT BESIDE THE BED. RESUSCITATIVE MEASURES WERE UNSUCCESSFUL. RESIDENT HAD A LOW BED WITH MAT ON THE FLOOR. THEY WERE FOUND ON LEFT SIDE WITH HEAD, FACE DOWN BETWEEN ASSISTIVE RAIL AND MATTRESS. DISTANCE FROM MAT TO BOTTOM OF RAIL WAS APPROX 11 INCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRAIL ASSISTIVE BED RAIL FNJ ALIMED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other