BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDROTHERMAL ABLATOR

    MDR report key: 416843 · Received September 16, 2002

    Report

    Report Number
    416843
    Event Type
    Other
    Date Received
    September 16, 2002
    Date of Event
    June 28, 2002
    Report Date
    August 22, 2002
    Manufacturer
    BEI MEDICAL SYSTEMS
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SUSTAINED THIRD DEGREE BURNS FOLLOWING HYDROTHERMIC ABLATION FOR ENDOMETRIOSIS. BURNS WERE NOT NOTED DURING HOSPITALIZATION. THEY WERE FOUND DURING FOLLOW-UP VISIT TO PHYSICIAN'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMAL ABLATOR HYDROTHERMAL ABLATOR MNB BEI MEDICAL SYSTEMS 56000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other