BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEM CORD

    MDR report key: 785464 · Received November 3, 2006

    Report

    Report Number
    1722040-2006-00009
    Event Type
    Other
    Date Received
    November 3, 2006
    Date of Event
    October 6, 2006
    Manufacturer
    ENCISION, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED AND CONTACT COULD NOT PROVIDE LOT CODE, BUT SHIPPING DATA SHOWS IT LIKELY WAS LOT JF, MANUFACTURED IN MAY, 2004.

    Description of Event or Problem · 1

    HOSPITAL REPORTED ARCING/SPARKING AT THE PLUG OF THE ELECTROSURGICAL CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM CORD ACTIVE ELECTRODE MONITORING SYSTEM GEI ENCISION, INC. ES4007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other