BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER ET

    MDR report key: 2874256 · Received December 14, 2012

    Report

    Report Number
    1720381-2012-00064
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT CONTACTING THE USER FACILITY TO OBTAIN PATIENT TREATMENT SETTINGS AND PATIENT PHOTOGRAPHS. LUMENIS RECEIVED TREATMENTS SETTINGS AND PHOTOGRAPHS OF THE DEVICE OPERATOR'S ANKLE. REASONABLE ATTEMPTS WERE MADE TO OBTAIN INFORMATION ABOUT THE PATIENT, HOWEVER NONE WAS RECEIVED. THE USER FACILITY DECLINED SERVICE OF THE SUBJECT DEVICE BY LUMENIS TECHNICAL REPRESENTATIVE. A REVIEW OF THE SERVICE RECORDS FOR THE SUBJECT DEVICE CONCLUDED THAT NO SERVICE HAD BEEN PERFORMED BY LUMENIS ON THE SUBJECT DEVICE SINCE (B)(4) 2010. LUMENIS CANNOT RULE OUT THAT SERVICE BY UNAUTHORIZED THIRD PARTY SERVICE PROVIDERS MAY HAVE CONTRIBUTED TO THE REPORTED ADVERSE EVENT. TO THE BEST OF LUMENIS' KNOWLEDGE, THE SUBJECT DEVICE REMAINS IN USE AT THE USER FACILITY. ABSENT SUBJECT DEVICE EXAMINATION, LUMENIS CANNOT DETERMINE A ROOT CAUSE FOR THE EVENTS REPORTED. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS CONCLUDING THE REPORTED TREATMENT SETTINGS WERE APPROPRIATE BASED ON COMMON MEDICAL PRACTICE. USER FACILITY DECLINED SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A USER FACILITY THAT ONE PATIENT SUSTAINED A SMALL BLISTER TO THE CHEEK AREA FOLLOWING TREATMENT WITH A LUMENIS LIGHTSHEER ET LASER. THE INITIAL REPORTER STATED THAT AFTER OBSERVING THE PATIENT'S REPORTED BURN THE DEVICE OPERATOR THEN TESTED THE SUBJECT DEVICE ON THEIR OWN ANKLE RESULTING IN HYPOPIGMENTED SPOTS. NO INFORMATION REGARDING MEDICAL INTERVENTION REQUIRED TO PRECLUDE SERIOUS INJURY WAS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other