BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER (ALL MODELS)

    MDR report key: 741602 · Received July 26, 2006

    Report

    Report Number
    2914019-2006-00062
    Event Type
    Other
    Date Received
    July 26, 2006
    Date of Event
    June 14, 2006
    Report Date
    July 26, 2006
    Manufacturer
    RH-USA
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS RECOMMENDED TO HAVE THE SYSTEM EVALUATED BY THE DEPOT. THE CUSTOMER DECLINED TO OBTAIN SERVICE. METHOD: THE TREATMENT PARAMETERS COULD NOT BE EVALUATED, AS CUSTOMER DID NOT PROVIDE LUMENIS THIS INFORMATION. THE PATIENT HAD SUN EXPOSURE (SUN BURN) BEFORE THE TREATMENT AND DID NOT INFORM THE AESHETICIAN. THIS APPEARS TO BE THE ROOT CAUSE FOR THE INCIDENT. RESULTS AND CONCLUSION: SYSTEM WAS NOT EVALUATED BY LUMENIS. DEVICE STATUS COULD NOT BE DETERMINED. COULDN'T DETERMINE IF DEVICE CONTRIBUTED TO ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN THE COMPLAINT IN 2006. LUMENIS TRIED TO CONTACT THE CUSTOMER BY PHONE AND FAX FOR ADDITIONAL INFORMATION ON THE ALLEGED BURNED PATIENT NINE DAYS LATER, THE NEXT MONTH AND EIGHT DAYS LATER. THIS CUSTOMER DID NOT RETURN ANY CALL OR FAX LUMENIS ANY INFORMATION. ON 7/20/2006, THE CUSTOMER CONTACTED LUMENIS ABOUT THE INCIDENT. THE CUSTOMER REPORTED ONE PATIENT HAD HAIR REMOVAL TREATMENT ON BOTH ARMS. IT WAS REPORTED THAT THERE WERE BURNS, AND SQUARE SPOTS WITH SOME DISCOLORATION. SHE WAS GIVEN A PRESCRIPTION FOR GENTAMYCIN AND GIVEN AN OVER THE COUNTER OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER (ALL MODELS) INTENSE PULSE LIGHT DEVICE GEX RH-USA EC *

    Patients

    Seq Age Sex Outcome Treatment
    1 *