BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE MD

    MDR report key: 3576670 · Received January 7, 2014

    Report

    Report Number
    1222993-2014-00001
    Event Type
    Injury
    Date Received
    January 7, 2014
    Date of Event
    December 9, 2013
    Report Date
    January 7, 2014
    Manufacturer
    CYNOSURE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K091169
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYNOSURE INC, MADE SEVERAL GOOD FAITH EFFORT TO REACH OUT TO PHYSICIAN TO RECEIVE MORE INFORMATION AND WAS NOT SUCCESSFUL. THE HANDPIECE WAS SERVICED AND IS WORKING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE DOCTOR'S OFFICE CALLED BECAUSE THE HANDPIECE WAS NOT WORKING. TWO PATIENTS WERE COMPLAINING AND MIGHT HAVE CAUSED SOME BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9879 ELITE MD ELITE MD GEX CYNOSURE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention