BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE

    MDR report key: 3599693 · Received December 5, 2013

    Report

    Report Number
    1222993-2013-00015
    Event Type
    Malfunction
    Date Received
    December 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    CYNOSURE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K034030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD BEEN TANNING AND THIS WAS REPORTED TO THE CLINICIAN PRIOR TO TREATMENT, BUT THE TIME BETWEEN TANNING AND THE TREATMENT WAS UNKNOWN. CLINICIAN USED YAG TO HANDLE TANNED SKIN. PATIENT WAS GIVEN SAMPLES OF TOPICORT SPRAY.

    Description of Event or Problem · 1

    BLISTERS OCCURRED POST-TREATMENT. PATIENT REPORTED THAT SHE HAD EXPERIENCED BLISTERING DURING THE LAST COUPLE TREATMENTS. SECOND PATIENT EXPERIENCED SUPERFICIAL BURNS FROM SAME DEVICE, SEPARATE REPORT BEING FILED. (1222993-2013-00016).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632365 ELITE MEDICAL LASER SYSTEM GEX CYNOSURE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1