BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMEX

    MDR report key: 18491267 · Received January 11, 2024

    Report

    Report Number
    18491267
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 19, 2023
    Report Date
    December 28, 2023
    Manufacturer
    GF HEALTH PRODUCTS, INC.
    Product Code
    INN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: PATIENT WAS SHOWERING, LEG OF SHOWER CHAIR BENT. THERE WAS NO PATIENT INJURY. WEIGHT LIMIT OF THE CHAIR IS 350 LBS. THE PATIENT THAT FELL WAS APPROX. 85 LBS. THERE IS A BARCODE WITH THIS NUMBER UNDERNEATH IT: (B)(4). THERE IS ANOTHER STICKER THAT SAYS ITEM NUMBER: 7921A-4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888232 LUMEX CHAIR, ADJUSTABLE, MECHANICAL INN GF HEALTH PRODUCTS, INC. 7921A-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown