BEUDAMED
    FDA Adverse Event Other Summary report: N

    LLETZ 3MM BALL ELECTRODE

    MDR report key: 383151 · Received March 18, 2002

    Report

    Report Number
    1030322-2002-00001
    Event Type
    Other
    Date Received
    March 18, 2002
    Date of Event
    February 13, 2002
    Report Date
    February 14, 2002
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Product Code
    HGI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLASTIC INSULATION ON ELECTRODE MELTED ON VAGINAL TISSUE CAUSING BURN TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LLETZ 3MM BALL ELECTRODE ELECTROSURGICAL ELECTRODE HGI AARON MEDICAL INDUSTRIES ES06 2001-06-21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other