BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMERSION HYDROBATH

    MDR report key: 2990627 · Received March 5, 2013

    Report

    Report Number
    1219590-2013-00010
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    INVACARE CLEVELAND STREET
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER (B)(6) MODEL 2001 BATHER SN# (B)(4) SEAL IS DEFECTIVE, PER POLICY LIFETIME WARRANTY. PER (B)(6) PART NUMBER WAS PROVIDED TO HIM BY (B)(6) IN TECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93106 IMMERSION HYDROBATH 890.5100 ILJ INVACARE CLEVELAND STREET UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other