BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDART 620 IN COMBINATION WITH MEDART 459

    MDR report key: 3496467 · Received November 19, 2013

    Report

    Report Number
    8021543-2013-00001
    Event Type
    Other
    Date Received
    November 19, 2013
    Date of Event
    October 18, 2013
    Report Date
    November 15, 2013
    Manufacturer
    MEDART A/S
    Product Code
    GEX
    PMA / PMN Number
    K120573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SYSTEM HAS BEEN CAREFULLY TESTED. SYSTEM HAS BEEN SERVICED ACCORDING TO SUGGESTED SERVICE INTERVALS (2 YEAR INTERVALS) (SERVICE PERFORMED ON APRIL 2013). NO TECHNICAL ISSUES HAS EVER BEEN OBSERVED ON THIS PARTICULAR SYSTEM. MANY OTHER SIMILAR SYSTEMS HAS BEEN ON THE MARKED SINCE 2005, AND WITHOUT ANY OTHER SIMILAR REPORTS FROM ANY OTHER USERS. THE SAME USER HAS REPORTED ANOTHER UNUSUAL TREATMENT RESULT WITH THE SAME TYPE OF SYSTEM (SAME LASER, DIFFERENT SCANNER) IN MARCH 2013. AFTER THIS REPORTED RESULT, THE SYSTEM WAS ALSO CAREFULLY INSPECTED AND TESTED, AND FOUND TO OPERATE 100% ACCORDING TO SPECIFICATIONS. THIS REPORTING IS REGISTERED IN OUR SYSTEM AS (B)(4). AT THIS POINT, WE CAN NOT SUGGEST ANY REASON FOR THE RESULTS, BUT WILL WAIT FOR THE SUGGESTED MEETING WITH THE DOCTOR, AND WILL FOLLOW UP ACCORDINGLY.

    Description of Event or Problem · 1

    PT HAS UNDERTAKEN SKIN REJUVENATION TREATMENT. PT IS REPORTING UNUSUAL SKIN REACTION AFTER PROCEDURE. DOCTOR PERFORMING TREATMENT CLAIMS TO HAVE BEEN USING NORMAL SETTINGS ON EQUIPMENT - SETTINGS SIMILAR TO SETTINGS WHICH HAS BEEN USED ON GREATER THAN 50 OTHER PTS. SKIN REACTION AFTER PROCEDURE IS PRESENTED ON A PHOTO, AND SHOWS UNEVEN AND UNEXPECTED SKIN REACTION. WE DON'T HAVE DETAILS ON THE PT - A MEETING WITH THE DOCTOR HAS BEEN REQUESTED TO CLARIFY ALL PT AND TREATMENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598721 MEDART 620 IN COMBINATION WITH MEDART 459 MEDART INTENZ GEX MEDART A/S 620000 AND 459000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other