BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMEX

    MDR report key: 15461803 · Received September 21, 2022

    Report

    Report Number
    15461803
    Event Type
    Malfunction
    Date Received
    September 21, 2022
    Date of Event
    September 2, 2022
    Report Date
    September 13, 2022
    Manufacturer
    GF HEALTH PRODUCTS, INC.
    Product Code
    INN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS IN SHOWER SEATED ON SHOWER CHAIR. PATIENT'S HUSBAND WAS PRESENT AND PROVIDING ASSIST TO THE PATIENT AT THE TIME OF THE EVENT. PATIENT WAS SEATED AND WAS FINISHING UP DRYING OFF WHEN THE REAR RIGHT LEG OF THE SHOWER CHAIR BUCKLED CAUSING PATIENT TO FALL. PATIENT DENIED HITTING HEAD AND CAUGHT HERSELF ON HER LEFT HAND WHICH WAS SORE. PATIENT FALL SCORE WAS 3 MAKING PATIENT A LOW FALL RISK. PATIENT COMPLAINED OF SORENESS TO LEFT WRIST, LEFT KNEE, AND NECK. XRAY OF LEFT KNEE, LEFT HAND, AND CERVICAL SPINE COMPLETED. NO FRACTURES NOTED WITH ANY OF THE IMAGES. PATIENT DID REQUIRE MODIFICATIONS TO PAIN MANAGEMENT WITH ADDITION OF STRONGER/MORE PAIN MEDICATIONS, ICE, ELEVATION, AND WRAPPING AND SPLINTING OF LEFT WRIST. DEVICE HAS WEIGHT LIMIT OF 350 LBS WITH A PRINTED LABEL ON THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567769 LUMEX CHAIR, ADJUSTABLE, MECHANICAL INN GF HEALTH PRODUCTS, INC. 7921A-4

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA Female