BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONMED

    MDR report key: 923554 · Received October 4, 2007

    Report

    Report Number
    1720159-2007-00043
    Event Type
    Injury
    Date Received
    October 4, 2007
    Date of Event
    August 29, 2007
    Report Date
    September 4, 2007
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REP HAD ASKED IF WE COULD PROVIDE TO HIM INFORMATION RELATING TO WHO PURCHASED THE UNIT FROM CONMED. REP ALSO WANTED TO KNOW IF WE HAD LITERATURE INDICATING THAT THIS UNIT COULD OR COULD NOT BE USED FOR TATTOO REMOVAL. THE INFORMATION WE PROVIDED TO REP IS AS FOLLOWS: PURCHASER OF SUSPECT DEVICE: AFTER REVIEWING THE OPERATORS MANUAL FOR THE HYFRECATOR 2000, WE FOUND THERE TO BE NO INFO REGARDING TATTOO REMOVAL. THERE IS NO RECOMMENDATION/INSTRUCTION TO PERFORM SUCH A PROCEDURE WITH THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    REP, AN INVESTIGATOR FOR DEPARTMENT OF REGULATORY AGENCIES CONTACTED CONMED IN REGARDS TO AN ADVERSE EVENT INVOLVING A CONMED HYFRECATOR 2000 (MODEL NO. 7-900-115,). THE PURCHASE OF THIS PRODUCT WAS TRACED BACK TO COMPANY, AND WAS PURCHASED IN 2002. REP INDICATED THAT A NON-LICENSED INDIVIDUAL USED THE UNIT TO REMOVE A TATTOO. REP FURTHER INDICATED THAT THIS INDIVIDUALS ATTEMPT AT REMOVED LEAD TO 2ND AND 3RD DEGREE BURNS ON THE PERSON WHO HAD THE TATTOO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED HYFRECATOR 2000 GEI CONMED ELECTROSURGERY 7-900-115

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other