BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVATIVE PRODUCTS UNLIMITED, INC.

    MDR report key: 1651130 · Received April 2, 2010

    Report

    Report Number
    1833497-2010-00007
    Event Type
    Malfunction
    Date Received
    April 2, 2010
    Date of Event
    March 24, 2010
    Report Date
    April 1, 2010
    Manufacturer
    INNOVATIVE PRODUCTS UNLIMITED, INC.
    Product Code
    INN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE BEING WHEELED TO THE SHOWER ROOM IN A RECLINING SHOWER COMMODE CHAIR, A FRONT FITTING BROKE CAUSING THE CASTER TO FALL OUT AND THE RESIDENT TO PITCH FORWARD HITTING HIS SHOULDER ON THE WALL AND BREAKING HIS COLLARBONE. THE FITTING BROKE AROUND THE SCREW THAT HOLDS THE CASTER PLUG IN. THE RESIDENT REMAINS IN THE FACILITY. NO OTHER HEALTH ISSUES WERE AFFECTED. REPLACED FRAME THAT BROKE. NO OTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    WHILE BEING WHEELED TO THE SHOWER ROOM IN A RECLINING SHOWER COMMODE CHAIR, A FRONT FITTING BROKE CAUSING THE CASTER TO FALL OUT AND THE RESIDENT TO PITCH FORWARD HITTING HIS SHOULDER ON THE WALL AND BREAKING HIS COLLARBONE. THE FITTING BROKE AROUND THE SCREW THAT HOLDS THE CASTER PLUG IN. THE RESIDENT REMAINS IN THE FACILITY. NO OTHER HEALTH ISSUES WERE EFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVATIVE PRODUCTS UNLIMITED, INC. RECLINING SHOWER CHAIR INN INNOVATIVE PRODUCTS UNLIMITED, INC. SCC260 RC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK