BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M22

    MDR report key: 6167860 · Received December 12, 2016

    Report

    Report Number
    3004135191-2016-00042
    Event Type
    Injury
    Date Received
    December 12, 2016
    Date of Event
    August 27, 2016
    Report Date
    December 7, 2016
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K083733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT CONTACTING THE USER FACILITY TO OBTAIN PATIENT INFORMATION, PATIENT TREATMENT SETTINGS AND PATIENT PHOTOGRAPHS, WHICH WERE PROVIDED BY THE USER FACILITY. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED AFTER VERIFYING THAT ALL SYSTEM FUNCTIONS INCLUDING CALIBRATION, THE SUBJECT DEVICE OPERATED TO MANUFACTURE SPECIFICATIONS. NO DEVICE MALFUNCTION WAS REPORTED OR OBSERVED. SUBJECT DEVICE MALFUNCTION IS NOT THE SUSPECTED CAUSE OF THE EVENT REPORTED. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS AND PATIENT PHOTOGRAPHS CONCLUDING THAT FAILURE TO PERFORM A TEST PATCH ON DARK SKIN PRIOR TO A FULL TREATMENT, AND TO DETERMINE THE APPROPRIATE TREATMENT SETTINGS IN CONTRADICTION TO COMMON MEDICAL PRACTICE TO BE THE PROBABLE ROOT CAUSE OF THE EVENT REPORTED. A REVIEW OF THE SUBJECT DEVICE LABELING FOUND THAT THE SUBJECT DEVICE OPERATOR MANUAL STATES: THERE IS A SMALL CHANCE OF BURNS OCCURRING ON THE SKIN. TO REDUCE THE POSSIBILITY OF BURNS FROM OCCURRING, IT IS IMPORTANT TO CAREFULLY FOLLOW ALL TREATMENT INSTRUCTIONS, AND IN PARTICULAR TO PERFORM TEST PATCHES. ALWAYS PERFORM A TEST PATCH ON THE INTENDED TREATMENT AREA DURING THE FIRST TREATMENT SESSION.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED FIRST DEGREE BURNS WHICH RESULTED IN SCARRING TO THE LOWER FACE AREA FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS M22 IPL LASER. IT WAS FURTHER REPORTED THAT NO TEST PATCH WAS PERFORMED PRIOR TO TREATMENT IN CONTRADICTION TO DEVICE LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819090 M22 SOLID STATE AESTHETIC LASER DEVICE GEX LUMENIS, LTD. M22

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other