BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS ONE

    MDR report key: 2353244 · Received November 30, 2011

    Report

    Report Number
    3004135191-2011-00056
    Event Type
    Injury
    Date Received
    November 30, 2011
    Date of Event
    November 2, 2011
    Report Date
    November 30, 2011
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    PMA / PMN Number
    K060448
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT CONCLUDED THE DEVICE OPERATED TO MANUFACTURE SPECIFICATIONS. CALIBRATION WAS FOUND TO BE WITHIN ACCEPTABLE LIMITS. NO DEVICE MALFUNCTION WAS REPORTED OR OBSERVED. A LUMENIS HEALTHCARE PROFESSIONAL EVALUATED THE REPORTED EVENT DETAILS CONCLUDING THE PROBABLE CAUSE OF THE EVENTS TO BE FAILURE TO PERFORM A TEST PATCH TO DETERMINE APPROPRIATE TREATMENT SETTINGS PRIOR TO TREATMENT IN CONTRADICTION TO DEVICE LABELING AND COMMON MEDICAL PRACTICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE PATIENTS SUSTAINED SECOND DEGREE BURNS AND BLISTERS TO THE ABDOMEN, NECK AND CHEST RESPECTIVELY FOLLOWING HAIR REMOVAL TREATMENT WITH A LUMENIS ONE LASER. NO TEST PATCH WAS REPORTEDLY PERFORMED ON THE PATIENTS PRIOR TO TREATMENT. NO MEDICAL INTERVENTION WAS REPORTED TO PRECLUDE PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENIS ONE INTENSE PULSE LIGHT DELIVERY SYSTEM GEX LUMENIS LTD LUMENIS ONE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other