BEUDAMED
    FDA Adverse Event Other Summary report: N

    CYNOSURE SMARTLIPO

    MDR report key: 1220249 · Received October 31, 2008

    Report

    Report Number
    1222993-2008-00001
    Event Type
    Other
    Date Received
    October 31, 2008
    Date of Event
    April 1, 2008
    Report Date
    October 31, 2008
    Manufacturer
    CYNOSURE, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). "OTHER THERAPIES OR MEDICATIONS WHICH MAY INTERFERE WITH TREATMENT" IS CLEARLY STATED AS A PART OF CONTRAINDICATIONS. THE SITE IS REMINDED OF THIS CONTRAINDICATION.

    Description of Event or Problem · 1

    ON OCT 3 2008, CYNOSURE RECEIVED INFORMATION FROM DR. (B) (6) OF (B) (6) SKIN CARE IN (B) (6) THAT CYNOSURE SMARTLIPO LASER MIGHT HAVE CONTRIBUTED TO PATIENT SKIN INJURIES. INJURIES OCCURRED IN THE ABDOMINAL SKIN AREA. FOLLOWING THE INFUSION OF TUMESCENT ANESTHETIC SOLUTION, A NON-CYNOSURE DEVICE, KNOWN AS VASER, WAS USED FOR AN ULTRASONIC LIPOSUCTION PROCEDURE. AFTER THE TUMESCENT FLUID TOGETHER WITH THE LIPOLYZED FAT WERE ASPIRATED CYNOSURE SMARTLIPO LASER WAS USED FOR FURTHER LIPOLYSIS. THE PATIENT SUFFERED FROM SKIN INJURIES CONSISTENT WITH THERMAL INJURIES. CYNOSURE SERVICE DEPT CONTACTED THE SITE FOR LASER EVALUATION; BUT WAS NOT ACCEPTED TO THE SITE UNTIL (B) (6) 2008. THE LASER WAS TESTED AND FOUND TO PERFORM WITHIN CYNOSURE'S SPECIFICATIONS. CYNOSURE OFFERED TO PROVIDE ADDITIONAL IN-SERVICE TRAINING; HOWEVER, THE TRAINING DATE HAD BEEN POSTPONED BY THE SITE INDEFINITELY. FURTHER ATTEMPTS TO REQUEST FOR MORE DETAILED ADDITIONAL INFORMATION WERE NOT WELL-RECEIVED BY THE SITE AND THEREFORE, NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYNOSURE SMARTLIPO DERMATOLOGY LASER GEX CYNOSURE, INC. SMARTLIP MO53T3

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other VASER