BEUDAMED
    FDA Adverse Event Summary report: N

    LIGHTSHEER EC

    MDR report key: 3857164 · Received June 9, 2014

    Report

    Report Number
    1720381-2014-00038
    Date Received
    June 9, 2014
    Date of Event
    May 8, 2014
    Report Date
    June 9, 2014
    Manufacturer
    RH USA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K003614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REASONABLE ATTEMPTS BY PHONE AND EMAIL WERE MADE TO OBTAIN FURTHER INFORMATION FROM THE USER FACILITY FOR THE REPORTED EVENTS INCLUDING PATIENT INFORMATION, TREATMENT SETTINGS, SUN EXPOSURE AND PHOTOS, HOWEVER NONE WAS RECEIVED; THEREFORE, LUMENIS IS UNABLE TO EVALUATE TREATMENT PARAMETERS TO DETERMINE THEIR APPROPRIATENESS FOR TREATMENT AND TO DETERMINE A CAUSE. A LUMENIS TECHNICAL ENGINEER COMPLETED PERFORMANCE TESTS OF ALL SPECIFICATIONS CONCLUDING THAT THE DEVICE OPERATED TO MANUFACTURER'S SPECIFICATIONS. NO DEVICE MALFUNCTION WAS REPORTED OR OBSERVED. SUBJECT DEVICE MALFUNCTION IS NOT THE SUSPECTED CAUSE OF THE EVENT REPORTED. SHOULD ADDITIONAL INFORMATION BE PROVIDED WITH WHICH TO MAKE A DETERMINATION OF CAUSE, LUMENIS WILL FILE A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    A FOREIGN USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED A BURN OF UNKNOWN SEVERITY FOLLOWING TREATMENT WITH A LUMENIS LIGHTSHEER EC LASER. NO INFORMATION REGARDING MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333880 LIGHTSHEER EC SOLID STATE AESTHETIC LASER DELIVERY DEVICE GEX RH USA, INC. LIGHTSHEER EC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other