BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOMEDICS CRYOGUN

    MDR report key: 170739 · Received June 1, 1998

    Report

    Report Number
    1519132-1998-00032
    Event Type
    Injury
    Date Received
    June 1, 1998
    Date of Event
    July 3, 1997
    Report Date
    May 7, 1998
    Manufacturer
    CRYOMEDICS, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO A LETTER REC'D FROM AN ATTORNEY, A PT SUSTAINED SECOND DEGREE BURNS WHEN A CRYOSURGICAL INSTRUMENT MALFUNCTIONED DURING A CRYOSURGICAL PROCEDURE. IN CORRESPONDENCE FROM THE ATTORNEY, IT WAS STATED THAT THE DOCTOR HAD SOME PROBLEMS WITH THE EQUIPMENT, BUT DECIDED TO PERFORM THE PROCEDURE. MID-WAY THROUGH THE PROCEDURE, THE PT SUFFERED BURNS IN THE VAGINAL AREA.

    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 22 YR Required Intervention