BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE INJECTABLE MONOPOLAR EMG ELECTRODE

    MDR report key: 4193565 · Received October 14, 2014

    Report

    Report Number
    2939713-2014-00001
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    August 6, 2014
    Manufacturer
    CHALGREN ENTERPRISES, INC.
    Product Code
    IKT
    PMA / PMN Number
    K955335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER IS IN PROCESS OF GATHERING ADDITIONAL INFORMATION REGARDING THE ADVERSE EVENT AND IS WORKING WITH THE DISTRIBUTOR WHO REPORTED THIS INCIDENT TO OBTAIN THIS INFORMATION FROM THE END USER. MANUFACTURER HAS ALSO REQUESTED RETURN OF THE DEVICE THAT FAILED AND RETURN OF ANY UNUSED DEVICES FROM THAT LOT THAT THE END USER MAY HAVE FOR FURTHER ANALYSIS AND TESTING TO DETERMINE A POSSIBLE ROOT CAUSE OF THE FAILURE. UPDATES REGARDING THIS INCIDENT WILL BE SUBMITTED WHEN AVAILABLE.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED AN ADVERSE EVENT ON (B)(6) 2014 REGARDING INJURY TO PT DURING A PROCEDURE INJECTING BOTULINUM TOXIN INTO A PT'S NECK. THIS PROCEDURE WAS PERFORMED BY A MEDICAL DOCTOR IN (B)(6). THE NEEDLE BROKE DURING THIS PROCEDURE AND REQUIRED SURGICAL REMOVAL. NO OTHER INFORMATION HAS BEEN MADE AVAILABLE REGARDING DETAILS OF THE EVENT SUCH AS: WHO THE INITIAL REPORTER IS (PHYSICIAN), DETAILS ON THE CONDITION OF THE PT, HOW SERIOUS THE INJURY WAS, OR WHEN AND WHERE (WHICH MEDICAL FACILITY) THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650133 DISPOSABLE INJECTABLE MONOPOLAR EMG ELECTRODE ELECTRODE, NEEDLE, DIAGNOSTIC EMG IKT CHALGREN ENTERPRISES, INC. X257

    Patients

    Seq Age Sex Outcome Treatment
    1 Other