BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEISEGANG

    MDR report key: 149230 · Received February 17, 1998

    Report

    Report Number
    MW1012998
    Event Type
    Other
    Date Received
    February 17, 1998
    Date of Event
    December 4, 1997
    Report Date
    February 17, 1998
    Manufacturer
    LEISEGANG MEDICAL, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CRYOTHERAPY UNIT IS USED TO FREEZE VAGINAL WARTS. DURING A TREATMENT BY A PHYSICIAN, AN O-RING FAILED. AS A RESULT OF THE O-RING FAILURE, LIQUID NITROGEN WAS SPRAYED OVER A WIDE AREA OF THE VAGINA AND ONTO THE PT'S LT ARM. THE RESULTING BURNS WERE CLASSIFIED AS "SUPERFICIAL AND MINOR" BY THE CLINIC PERSONNEL. NO BLISTERS WERE OBSERVED AND NO TREATMENT PRESCRIBED. THE ARM WAS REPORTEDLY SLIGHTLY RED. THE PT WAS RELEASED FROM THE CLINIC, BUT LATER THAT DAY WENT TO THE ED. THE RPTR IS UNSURE IF ANY TREATMENT WAS PERFORMED OR PRESCRIBED AT THE ED. THE O-RING HAS BEEN REPLACED AND THE UNIT IS BACK IN SVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEISEGANG CRYOTHERAPY UNIT GEH LEISEGANG MEDICAL, INC. LM-900 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other