BEUDAMED
    FDA Adverse Event Other Summary report: N

    ND: YAG 1064NM LASER

    MDR report key: 2272440 · Received September 29, 2011

    Report

    Report Number
    2954354-2011-00023
    Event Type
    Other
    Date Received
    September 29, 2011
    Date of Event
    July 14, 2011
    Report Date
    September 28, 2011
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD MEDICAL HISTORY OF "VARICOSE VEINS". CUTERA DOES NOT RECOMMEND TREATING "VARICOSE VEINS" WITH THE CUTERA ND: YAG 1064NM LASER. THE LASER OPERATOR HAD NOT RECEIVED CUTERA MANUFACTURER'S TRAINING ON THE DEVICE. THE ADVERSE EVENT DEVELOPED AFTER A VASCULAR TREATMENT DURING A SALES DEMO FOR A POTENTIAL VASCULAR UPGRADE THE PHYSICIAN PERFORMED THE TREATMENT. THE LASER SYSTEM WAS EVALUATED 3 DAYS PRIOR TO THE SALES DEMO AND FOUND TO BE OPERATING WITHIN SPECIFICATION. THE LASER WAS EVALUATED AFTER THE ADVERSE EVENT AND FOUND TO BE OPERATING WITHIN SPECIFICATION. THERE WAS NO EVIDENCE OF DEVICE FAILURE. "BURNS, BLISTERS AND SCARRING" ARE LISTED IN CUTERA OPERATOR MANUAL AS "EXPECTED TRANSIENT EVENTS AND POSSIBLE ADVERSE EFFECTS". THE PATIENT WAS PRESCRIBED "ANTIBIOTIC OINTMENT" AS TREATMENT.

    Description of Event or Problem · 1

    PATIENT DEVELOPED "BLISTER" AFTER ND:YAG 1064NM LASER VASCULAR TREATMENT. THE AREA APPROXIMATELY THE SIZE OF AN "ERASER AT THE END OF A PENCIL". THE AREA REQUIRED MEDICAL INTERVENTION TO PREVENT SCAR FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ND: YAG 1064NM LASER ND: YAG 1064NM LASER GEX CUTERA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention