BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANUAL HOSPITAL BED

    MDR report key: 22278 · Received June 7, 1995

    Report

    Report Number
    MW1006171
    Event Type
    Injury
    Date Received
    June 7, 1995
    Report Date
    May 25, 1995
    Manufacturer
    NOA MEDICAL INDUSTRIES, INC.
    Product Code
    FNJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MR. CADWELLENDER WANTS 100 SETS OF UNIVERSAL SAFETY SIDE RAILS FROM US. AS POINTED OUT IN OUR LETTER OF 5/8/95 TO MR. CADWELLENDER, HIS BEDS ARE OVER (2) YEARS OLD AND WE CANNOT TAKE BACK HIS RAILS AND REPLACE THEM. HIS CO BOUGHT OUR BED WITH FULL KNOWLEDGE OF THE BED AND ITS DIMENSIONS AND SIDE RAIL CAPABILITIES. WE DON'T KNOW HOW TO MFG A BED THAT WILL KEEP A 94# PERSON FROM GETTING BETWEEN THE MATTRESS AND THE SIDE RAIL IF THE CARE PROVIDER USES A STANDARD MATTRESS. NOR, DO WE KNOW HOW TO PREVENT A 94# PT FROM PUTTING THEIR ARMS OR LEGS THROUGH A SIDE RAIL UNLESS THE NURSING HOME PROVIDES SPECIAL MATTRESSES OR BOLSTERS FOR SPECIAL PEOPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL HOSPITAL BED MANUAL RESIDENT BED FNJ NOA MEDICAL INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening