BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOWER CHAIR

    MDR report key: 3880319 · Received June 13, 2014

    Report

    Report Number
    MW5036648
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 25, 2014
    Report Date
    June 12, 2014
    Manufacturer
    GUARDIAN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USING A GUARDIAN BRAND SHOWER CHAIR, MODEL #99000, SERIAL NUMBER (B)(4). PLASTIC SUPPORT BAR UNDER THE SEAT OF THE CHAIR BROKE AT THE CORNER WHERE SCREW WAS. THIS CAUSED THE METAL SUPPORT TO BREAK AND CAUSE A PENETRATING RECTAL INJURY. PT'S WEIGHT WAS (B)(6). CHAIR RATE FOR 300#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350028 SHOWER CHAIR SHOWER CHAIR IKX GUARDIAN 99000

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization