BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOMEDICS CRYOGUN

    MDR report key: 170736 · Received June 1, 1998

    Report

    Report Number
    1519132-1998-00034
    Event Type
    Injury
    Date Received
    June 1, 1998
    Date of Event
    May 22, 1997
    Report Date
    May 13, 1998
    Manufacturer
    CRYOMEDICS, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO INFO REC'D FROM AN ATTORNEY, DURING A CRYOSURGICAL PROCEDURE TO REMOVE VAGINAL WARTS, A "CRACK DEVELOPED" IN THE DEVICE RESULTING IN A BURN OF APPROXIMATELY ONE INCH BY TWO INCHES ON THE LEFT SIDE OF THE PT'S VAGINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOMEDICS CRYOGUN CRYOSURGICAL UNIT GEH CRYOMEDICS, INC. MT-600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention