BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARI-TIP WIRE ELECTRODE

    MDR report key: 6032011 · Received October 15, 2016

    Report

    Report Number
    2428235-2016-00008
    Event Type
    Injury
    Date Received
    October 15, 2016
    Date of Event
    September 15, 2016
    Report Date
    October 15, 2016
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    GEI
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISPOSABLE DEVICE UNABLE TO BE EVALUATED AS IT WAS DISCARDED AND NOT RETURNED. INITIAL REPORTER UNRESPONSIVE REGARDING CURRENT PATIENT CONDITION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT PROCEDURE FOR TONSILLECTOMY; ELECTRODE BECAME DETACHED FROM THE SHEATH, WHILE THE WIRE REMAINED LODGED IN THE PATIENT'S MOUTH, RESULTING IN BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683187 VARI-TIP WIRE ELECTRODE VARI-TIP WIRE ELECTRODE GEI CYNOSURE, INC. DBA ELLMAN A8D 20160201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other