BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER DUET

    MDR report key: 3080713 · Received April 26, 2013

    Report

    Report Number
    3004135191-2013-00032
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 26, 2013
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K053628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THE DEVICE OPERATED TO MANUFACTURE SPECIFICATIONS. NO DEVICE MALFUNCTION WAS REPORTED OR OBSERVED. SUBJECT DEVICE MALFUNCTION IS NOT THE SUSPECTED ROOT CAUSE OF THE EVENT REPORTED. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS AND PATIENT PHOTOGRAPH'S CONCLUDING THE REPORTED TREATMENT SETTINGS WERE APPROPRIATE BASED ON COMMON MEDICAL PRACTICE AND DEVICE LABELING. ADDITIONALLY, THE HEALTHCARE PROFESSIONAL STATED THAT FAILURE TO PERFORM A TEST PATCH ON DARK SKIN PRIOR TO TREATMENT TO DETERMINE APPROPRIATE TREATMENT SETTINGS IN CONTRADICTION TO COMMON MEDICAL PRACTICE TO BE THE PROBABLE ROOT CAUSE OF THE EVENT REPORTED. A REVIEW OF DEVICE LABELING CONFIRMED THAT TEST PATCH IS ADVISED FOR PATIENTS OF DARKER SKIN TYPES. DEVICE LABELING STATES: "ALWAYS PERFORM A TEST PATCH ON THE INTENDED TREATMENT AREA DURING THE FIRST TREATMENT SESSION." "FOR SKIN STYLES V AND VI, WAIT AT LEAST 48 TO 72 HOURS AFTER PERFORMING THE TEST SPOT TO OBSERVE SKIN TISSUE REACTION; AND ADJUST PARAMETERS AS NEEDED." CAUTION - "PERFORM TEST SPOTS ON PATIENTS AND ASSESS SIDE EFFECTS BEFORE PERFORMING A FULL TREATMENT. SIDE EFFECTS MAY NOT DEVELOP UNTIL SEVERAL DAYS FOLLOWING EXPOSURE. THE RISK OF SIDE EFFECTS IS GREATER ON DARK-SKINNED PATIENTS, HOWEVER, LIGHT-SKINNED PATIENTS MAY ALSO DEVELOP SIDE EFFECTS."

    Description of Event or Problem · 1

    IT WAS REPORTED BY A USER FACILITY THAT A PATIENT WITH SKIN TYPE VI SUSTAINED HYPOPIGMENTATION TO THE CHIN AND UPPER LIP AREA FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER DUET LASER. IT WAS FURTHER REPORTED THAT NO TEST PATCH WAS PERFORMED PRIOR TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180917 LIGHTSHEER DUET SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX LUMENIS, LTD. LIGHTSHEER DUET

    Patients

    Seq Age Sex Outcome Treatment
    1 39 Other