BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A&E MEDICAL ELECTROSURGICAL PENCIL

    MDR report key: 1231111 · Received October 30, 2008

    Report

    Report Number
    2242056-2008-00001
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 2, 2008
    Manufacturer
    ALTO DEVELOPMENT CORP.
    Product Code
    GEI
    PMA / PMN Number
    K915300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE EFFECTS TO USER OR PATIENT REPORTED.

    Description of Event or Problem · 1

    INADVERTENT ACTIVATION OF ELECTROSURGICAL PENCIL. NO ADVERSE EFFECTS TO USER OR PATIENT REPORTED. THIS REPORT IS SUBMITTED TO MEET MDR REGULATIONS. THE REPORTED EVENT IS UNSUBSTANTIATED AND UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A&E MEDICAL ELECTROSURGICAL PENCIL ELECTROSURGICAL PENCIL GEI ALTO DEVELOPMENT CORP. 042A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other