BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AARON

    MDR report key: 406669 · Received July 22, 2002

    Report

    Report Number
    1030322-2002-00010
    Event Type
    Injury
    Date Received
    July 22, 2002
    Date of Event
    June 7, 2002
    Report Date
    June 28, 2002
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL REVISION OF A LOWER BLEPHAROPLASTY THE ARCING OCCURRED CAUSING BURNS TO THE PT AROUND THE EYE AREA WHERE SURGICAL REVISION WAS BEING PERFORMED. DR PROCEEDED TO REMOVE BURNED TISSUE. EXPECTS THAT SCAR WILL BE LARGER THAN ANTICIPATED. UNIT WAS SET AT COAG 1 WHEN ARCING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AARON HIGH FREQUENCY ELECTROSURGICAL GENERATOR GEI AARON MEDICAL INDUSTRIES A1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention