BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE LM 900 CRYO

    MDR report key: 231102 · Received June 23, 1999

    Report

    Report Number
    231102
    Event Type
    Injury
    Date Received
    June 23, 1999
    Date of Event
    June 16, 1999
    Report Date
    June 23, 1999
    Manufacturer
    LEISEGANG MEDICAL, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CRYOSURGICAL PROCEDURE, THE LM 900 CRYO INSTRUMENT MALFUNCTIONED CAUSING INJURY TO THE PT'S VAGINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE LM 900 CRYO CRYO SURGICAL INSTRUMENT GEH LEISEGANG MEDICAL, INC. LM 900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention