BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE INJECTABLE MONOPOLAR EMG ELECTRODE

    MDR report key: 4232445 · Received October 14, 2014

    Report

    Report Number
    2939713-2014-00002
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    August 4, 2014
    Report Date
    October 7, 2014
    Manufacturer
    CHALGREN ENTERPRISES, INC.
    Product Code
    IKT
    PMA / PMN Number
    K955335
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER HAS REQUESTED RETURN OF THE DEVICE THAT FAILED FOR EVALUATION OF POSSIBLE ROOT CAUSE(S) OF THE FAILURE OF THE DEVICE. INITIALLY, THE REPORTER OF THE EVENT INDICATED THAT THE DEVICE COULD NOT BE SENT BACK SINCE IT WAS BEING EVALUATED BY THE RISK MANAGEMENT TEAM. THE DR. HAS REQUESTED THAT FURTHER EVALUATION OF THE FAILURE BE CONDUCTED, SO (B)(4)WAS CONTACTED ON (B)(4) 2014 THAT THE DEVICE WILL BE RETURNED . (B)(4) WAS ALSO NOTIFIED ON (B)(4) 2014 THAT THIS EVENT WAS REPORTED TO THE FDA. UPDATES REGARDING THIS INCIDENT WILL BE SUBMITTED WHEN AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    REPORT FROM CUSTOMER THAT THE NEEDLE FROM AN INJECTABLE EMG NEEDLE ELECTRODE BROKE IN PATIENT'S ARM NEAR THE HUB DURING A LIMB DYSTONIA PROCEDURE AND WAS RETAINED IN THE TISSUE. A DECISION WAS MADE BY THE MEDICAL STAFF NOT TO PERFORM ANY INTERVENTION TO RETRIEVE THE NEEDLE FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649819 DISPOSABLE INJECTABLE MONOPOLAR EMG ELECTRODE ELECTRODE, NEEDLE, DIAGNOSTIC EMG IKT CHALGREN ENTERPRISES, INC. 242-025-24TP X257

    Patients

    Seq Age Sex Outcome Treatment
    1 Other