BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYNERGY

    MDR report key: 4960209 · Received August 3, 2015

    Report

    Report Number
    1222993-2015-00034
    Event Type
    Injury
    Date Received
    August 3, 2015
    Report Date
    August 3, 2015
    Manufacturer
    CYNOSURE INC
    Product Code
    GEX
    PMA / PMN Number
     K050779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL ATTEMPTS WERE MADE TO CONTACT THE DOCTOR IN ORDER TO GAIN ADDITIONAL INFORMATION ON THE PATIENT'S POST TREATMENT CARE, TREATMENT PARAMETERS, AND CURRENT STATUS. HOWEVER ALL WERE UNSUCCESSFUL BECAUSE THE DOCTOR NEVER RESPONDED TO OUR REQUESTS TO FURTHER INVESTIGATE THE INCIDENT. SINCE THE PATIENT EXPERIENCED A SCAR FROM THE LASER TREATMENT, THIS IS A REPORTABLE EVENT. THERE WAS NO PROBLEM FOUND WITH THE LASER DEVICE AND OPERATED WITHIN SPECIFICATION DURING A SERVICE EVALUATION.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A SCAR ON UPPER LIP FROM A LASER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503860 CYNERGY CYNERGY GEX CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other