BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS ONE

    MDR report key: 6830061 · Received August 30, 2017

    Report

    Report Number
    3004135191-2017-00120
    Event Type
    Injury
    Date Received
    August 30, 2017
    Date of Event
    September 22, 2016
    Report Date
    October 22, 2017
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K060448
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS CONTACTED THE USER FACILITY DIRECTLY TO OBTAIN PATIENT INFORMATION, TREATMENT SETTINGS, AND PATIENT PHOTOGRAPHS, WHICH HAVE BEEN PROVIDED. NO MALFUNCTION HAS BEEN REPORTED BY THE USER FACILITY, HOWEVER; A REVIEW OF SUBJECT DEVICE SERVICE RECORDS CONCLUDED THAT NO SERVICE HAS BEEN PERFORMED BY LUMENIS SINCE (B)(6) 2015. 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. A LUMENIS CLINICAL MANAGER, BEING A PERSON QUALIFIED TO MAKE A MEDICAL JUDGEMENT, IS CURRENTLY REVIEWING THE REPORTED EVENT DETAILS AND PATIENT TREATMENT SETTINGS TO DETERMINE THE APPROPRIATENESS OF TREATMENT AND EVALUATE THE SEVERITY OF HARM. LUMENIS IS CONTINUING ITS INVESTIGATION AND WILL FILE A FOLLOW-UP MDR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS CONCLUDING THE REPORTED TREATMENT SETTINGS WERE APPROPRIATE BASED ON COMMON MEDICAL PRACTICE, DEVICE LABELING, AND DEVICE TRAINING FOR THE REPORTED PATIENT SKIN TYPE. THE HEALTHCARE PROFESSIONAL CONCLUDED THAT PROBABLE SUN EXPOSURE TO BE THE CONTRIBUTORY CAUSE OF THE REPORTED EVENT. BASED ON THE NEW INFORMATION, LUMENIS IS CHANGING THE CONCLUSIONS CODES ACCORDINGLY.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED SCRATCH LIKE MARKS AND HYPOPIGMENTATION ON ((B)(6) 2016) TO THE LEGS AREA FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS ONE LASER, HS HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611184 LUMENIS ONE INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS, LTD. LUMENIS ONE

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other