BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE MPX

    MDR report key: 6175228 · Received December 15, 2016

    Report

    Report Number
    1222993-2016-00057
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 12, 2016
    Report Date
    December 14, 2016
    Manufacturer
    CYNOSURE INC
    Product Code
    GEX
    PMA / PMN Number
    K091169
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION INTO THE PATIENT'S ALLEGED BURN, IT WAS LATER CONFIRMED THAT INSTEAD THE PATIENT ONLY HAD A SMALL BLISTER WHICH RESOLVED ON ITS OWN. PATIENT DID VISIT AN URGENT CARE CENTER FOR POST TREATMENT CARE AND WAS SUGGESTED TO TAKE SUNBLOCK AND FLAMAZINE TOPICAL MEDICATION FOR HEALING. BLISTERS ARE AN EXPECTED SIDE EFFECT FROM LASER TREATMENTS. THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATING OUT OF SPECIFICATION (ON THE HIGHER END), BEYOND THE +/- 20% RANGE. CYNOSURE'S SERVICE TECHNICIAN PERFORMED REPAIRS BY REPLACING THE DEVICE'S BEAM-BLOCK ASSEMBLY AND YAG WAVELENGTH LAMP COMPONENTS TO RESOLVE THE ISSUE. THIS IS REPORTABLE BECAUSE THE DEVICE WAS FOUND OPERATING BEYOND THE ACCEPTABLE SPECIFICATION RANGE AND PATIENT HAD MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    PATIENT DEVELOPED AN ALLEGED 3RD DEGREE BURN ON RIGHT OF FACE FROM A LASER HAIR REMOVAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829696 ELITE MPX ELITE MPX GEX CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other