BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAZ REHAB SHOWER CHAIR (HCPCS #E0240)

    MDR report key: 9654285 · Received January 30, 2020

    Report

    Report Number
    MW5092673
    Event Type
    Injury
    Date Received
    January 30, 2020
    Date of Event
    March 20, 2017
    Report Date
    January 22, 2020
    Manufacturer
    RAZ DESIGN INC.
    Product Code
    INN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    WHILE (B)(6) WAS SHOWERING USING THE SHOWER CHAIR ON (B)(6) 2017, THE SEAT COMPLETELY GAVE WAY, COLLAPSING AND CAUSING ONE OF THE STAINLESS STEEL RODS THAT SUPPORT THE SEAT TO IMPALE HIS ANUS AND COLON. HIS COLON WAS PERFORATED IN SIX DIFFERENT PLACES. THIS WIRE REMOVED THE ROD FROM HIS RECTUM BEFORE EMERGENCY RESPONDERS ARRIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113051 RAZ REHAB SHOWER CHAIR (HCPCS #E0240) CHAIR, ADJUSTABLE MECHANICAL INN RAZ DESIGN INC. SP

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| S