BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR KIT

    MDR report key: 372010 · Received January 15, 2002

    Report

    Report Number
    MW1023847
    Event Type
    Malfunction
    Date Received
    January 15, 2002
    Date of Event
    December 17, 2001
    Report Date
    January 7, 2002
    Manufacturer
    BEI MEDICAL SYSTEMS
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PIECE CAME OFF AND WAS RETAINED IN PT'S VAGINA. PT BROUGHT IT INTO THE DR'S OFFICE. EDUCATION ON DEVICE USE SHOULD INCLUDE THIS RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRO THERMABLATOR KIT HYSTEROSCOPIC ABLATION DEVICE MNB BEI MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other