BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMERSION HYDROBATH

    MDR report key: 3892507 · Received June 24, 2014

    Report

    Report Number
    1219590-2014-00093
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    May 27, 2014
    Manufacturer
    INVACARE CLEVELAND STREET
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE DOOR ON AN (B)(4) SIDE ENTRY WHIRLPOOL TUB HAS A GAP BETWEEN THE SEAL AND TUB OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367782 IMMERSION HYDROBATH 890.5100 ILJ INVACARE CLEVELAND STREET IH3652G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other