BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER ET

    MDR report key: 3759889 · Received April 18, 2014

    Report

    Report Number
    1720381-2014-00027
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 5, 2014
    Report Date
    April 17, 2014
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE EVENT REPORT CONTACTING THE DISTRIBUTOR TO REQUEST PATIENT TREATMENT SETTINGS AND PATIENT PHOTOGRAPHS, WHICH WERE PROVIDED. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THE DEVICE OPERATED TO MANUFACTURER SPECIFICATIONS. NO DEVICE MALFUNCTION WAS OBSERVED. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS AND PATIENT PHOTOGRAPH CONCLUDING THE REPORTED TREATMENT SETTINGS WERE APPROPRIATE BASED ON COMMON MEDICAL PRACTICE AND DEVICE LABELING. FURTHERMORE; THE PROFESSIONAL CONCLUDED THE PROBABLE ROOT CAUSE TO BE DEBRIS BUILD UP ON THE TREATMENT TIP AS A RESULT OF INSUFFICIENT CLEANING BY THE USER FACILITY IN CONTRADICTION TO DEVICE LABELING. A REVIEW OF SUBJECT DEVICE LABELING FOUND THE FOLLOWING PRECAUTIONARY STATEMENTS: "WARNING - THE SAPPHIRE TIP OF THE HANDPIECE MUST BE KEPT CLEAN DURING PATIENT TREATMENT. FOREIGN MATTER ON THE TIP WILL GET HOT DUE TO ABSORPTION OF LASER LIGHT AND CAN CAUSE EPIDERMAL INJURY AND SUBSTANTIALLY INCREASED PAIN."

    Description of Event or Problem · 1

    A FOREIGN DISTRIBUTOR REPORTED THAT A PATIENT OF SKIN TYPE IV SUSTAINED HYPERPIGMENTATION TO THE LOWER LEGS FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS LIGHTSHEER ET LASER. NO INFORMATION REGARDING A REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237699 LIGHTSHEER ET SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX RH USA, INC. LIGHTSHEER ET

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other