BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE

    MDR report key: 3063291 · Received April 11, 2013

    Report

    Report Number
    1222993-2013-00002
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 12, 2013
    Manufacturer
    CYNOSURE, INC.
    Product Code
    GEX
    PMA / PMN Number
    PP2814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ONSITE EVAL OF THE LASER WAS PERFORMED AND IT WAS NOTED THAT DEVICE WAS PREVIOUSLY DAMAGED. FURTHER EVAL OF THE DEVICE MAY BE PERFORMED IF DEVICE IS RETURNED.

    Description of Event or Problem · 1

    INCIDENT OCCURRED IN (B)(6). THE LASER ACTIVATED IN A MODE THAT IS NOT INTENDED TO ALLOW THE LASER TO ACTIVATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154548 ACCOLADE DERMATOLOGY LASER SYSTEM GEX CYNOSURE, INC. 100-7008-010

    Patients

    Seq Age Sex Outcome Treatment
    1