BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVATIVE PRODUCTS UNLIMITED, INC.

    MDR report key: 1505823 · Received September 17, 2009

    Report

    Report Number
    1833497-2009-00002
    Event Type
    Malfunction
    Date Received
    September 17, 2009
    Date of Event
    August 7, 2009
    Report Date
    September 16, 2009
    Manufacturer
    INNOVATIVE PRODUCTS UNLIMITED, INC.
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FRONT LEFT OF CHAIR CAME LOOSE AND SEPARATED, CAUSING THE CHAIR TO LEAN FORWARD. WAITED TO RECEIVE THE CHAIR FOR EVAL BEFORE FILING THIS REPORT.

    Description of Event or Problem · 1

    RESIDENT WAS IN SHOWER ROOM SITTING ON THE SHOWER CHAIR. WHEN THE CNA REPOSITIONED THE CHAIR TO THE LEFT, THE FRONT LEFT LEG OF THE SHOWER CHAIR BROKE, CAUSING THE RESIDENT TO LEAN FORWARD AND HIT THE WALL, RESULTING IN A 3 CM BRUISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVATIVE PRODUCTS UNLIMITED, INC. SHOWER CHAIR INM INNOVATIVE PRODUCTS UNLIMITED, INC. SCC250 OS FS

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR