BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS ONE

    MDR report key: 1895468 · Received November 4, 2010

    Report

    Report Number
    2914019-2010-00050
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 4, 2010
    Manufacturer
    LUMENIS LTD., YOKNEAM
    Product Code
    GEX
    PMA / PMN Number
    K060448
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REASONABLE ATTEMPTS BY PHONE AND FAX WERE MADE TO OBTAIN TREATMENT SETTINGS, PATIENT INFO, AND MEDICAL INTERVENTION INFO, HOWEVER, NONE WAS RECEIVED. AN EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SUBJECT MATTER EXPERT CONCLUDED THAT NO RELATED DEVICE MALFUNCTION OCCURRED AND THAT THE DEVICE OPERATED WITHIN MFR SPECIFICATIONS. A REVIEW OF SERVICE RECORDS CONCLUDED THAT THE USER FACILITY HAD THE DEVICE SERVICED WITHIN A YEAR. LUMENIS IS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED BLISTERS ON THE LEFT CALF AFTER HAIR REMOVAL TREATMENT WITH A LUMENIS ONE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENIS ONE INTENSE PULSE LIGHT DEVICE GEX LUMENIS LTD., YOKNEAM GAL170000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK