BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BED BOLSTER

    MDR report key: 14613 · Received July 12, 1994

    Report

    Report Number
    MW1002780
    Event Type
    Malfunction
    Date Received
    July 12, 1994
    Date of Event
    May 1, 1994
    Report Date
    June 26, 1994
    Manufacturer
    SKIL-CARE CORP.
    Product Code
    FMQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE USED AS RESTRAINT ALTERNATIVE. STITCHING IN BOLSTER GAVE WAY AND RESIDENT ROLLED OVER IT AND OUT OF BED. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED BOLSTER BED BOLSTER FMQ SKIL-CARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *