BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUANTUM

    MDR report key: 822895 · Received February 12, 2007

    Report

    Report Number
    2914019-2007-00002
    Event Type
    Other
    Date Received
    February 12, 2007
    Date of Event
    January 4, 2007
    Report Date
    February 12, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE MFR, THE INTERNAL ADAPTOR WINDOW OF THE CUSTOMER'S POWER METER WAS OBSCURED AND BURNT AND THE CUSTOMER'S NEW SR 560 TREATMENT HEAD (WHICH HAD BEEN USED FOR THE PHYSICIAN TREATMENT) HAD A BURNED ON SUBSTANCE. THIS FOREIGN MATERIAL HAD RESULTED IN INCREASED DEVICE OUTPUT THAT WAS OUT OF SPECIFICATION. THE FOREIGN MATERIAL ON THE ENERGY METER WINDOW AND THE TREATMENT HEAD APPEAR TO BE THE ROOT CAUSE OF THE INCIDENT. PER THE MFR, THE CUSTOMER HAD USED AN OLDER SR560 TREATMENT HEAD DURING THE PROCEDURE, IN WHICH THE PATIENT WAS BURNED. THIS TREATMENT HEAD WAS NOT AVAILABLE FOR EVALUATION AS THE CUSTOMER HAD THROWN AWAY THIS TREATMENT HEAD, AFTER THE PATIENT INCIDENT. THE MFR RECOMMENDED THAT THE CUSTOMER REPLACE THE SR560 TREATMENT HEAD, SO THAT THE MFR COULD RETURN TO RECALIBRATE THE QUANTUM DEVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT HAD BRUISING AND BLISTERING AFTER IPL TREATMENT TO THE FACE IN 2007. THE PATIENT WAS GIVEN BACTROBAN OINTMENT 2% (PRESCRIPTION) AND WAS RECOMMENDED TO APPLY ZINC OXIDE SUNSCREEN. SEVEN DAYS LATER, THE BLISTERING WAS IMPROVING. AFTER THE PATIENT INJURY, THE PHYSICIAN TESTED THE QUANTUM DEVICE ON HERSELF WITH A NEWER SR560 TREATMENT HEAD AND WAS ALSO BURNED. MFR HAS REQUESTED ADDITIONAL DETAILS INCLUDING DEGREE OF THE BURNS TO THE PATIENT AND THE PHYSICIAN. AS OF 2/12/2007 THESE ADDITIONAL DETAILS HAVE NOT BEEN PROVIDED TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM OTHER GEX LUMENIS, INC. GA3687000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other REQUESTED AND NOT PROVIDED.