BEUDAMED
    FDA Adverse Event Other Summary report: N

    DENTO-SURG 90 F.F.P.F EMC

    MDR report key: 3772332 · Received March 26, 2014

    Report

    Report Number
    2428235-2014-00001
    Event Type
    Other
    Date Received
    March 26, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 24, 2014
    Manufacturer
    ELLMAN INTERNATIONAL
    Product Code
    EKZ
    PMA / PMN Number
    K955176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING RETURNED FROM (B)(6) AND WILL BE INSPECTED ONCE IT IS RECEIVED. ADDITIONAL INFORMATION IS ALSO BE REQUESTED FROM THE DISTRIBUTOR. ADDITIONAL INFORMATION REPORT(S) WILL BE FILED AS NECESSARY.

    Description of Event or Problem · 1

    A BLEPHAROPLASTY WAS BEING PERFORMED USING THE F.F.P.F. EMC GENERATOR. DURING THE PROCEDURE, THE EYELID WAS BURNED. THE BURN AREA WAS EXCISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178629 DENTO-SURG 90 F.F.P.F EMC RADIOFREQUENCY GENERATOR EKZ ELLMAN INTERNATIONAL EMCD220EU

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention