BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSCULPT

    MDR report key: 2910232 · Received January 8, 2013

    Report

    Report Number
    MW5028507
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    November 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    LUTRONIC CORP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD LASER ASSISTED LIPOLYSIS (REPORTED ERRONEOUSLY AS "SMART LIPO") THE DOCTOR INFORMED THE MANUFACTURER THAT THE LIPOLYSIS WAS TREATED ON UPPER AND LOWER ABDOMEN AND FRONT WRIST. ON (B)(6) 2012, THE PT CALLED THE DOCTOR AND WAS CONCERNED WITH BLISTERING AND PAIN IN THE AREA THAT WAS TREATED. PT WAS TOLD TO COME TO THE PHYSICIAN'S OFFICE. DR. (B)(6) DIAGNOSED A SECOND DEGREE BURN. DOCTOR PRESCRIBED TO PT COFTIN 500MG, SILVADENE, ALTABAX OINTMENT. THE PHYSICIAN NOTIFIED THE MANUFACTURER ON (B)(4) 2012 REGARDING THE EVENT. LUTRONIC IMMEDIATELY RESPONDED WITHIN 3 BUSINESS DAYS UPON RECEIPT OF COMPLAINT. THE LUTRONIC SYSTEM ENGINEER ASCERTAINED THAT THE SYSTEM WAS OPERATING WITHIN ALL SPECS AND WAS IN GOOD CONDITION, HOWEVER, THE CUTTING TOOL USED BY THE DOCTOR WAS IN POOR CONDITION. HE DEMONSTRATED TO THE LASER NURSE THERE AT THE TIME, THE DIFFERENCE BETWEEN A GOOD FIBER CUT AND THE CUT DONE BY THE DOCTOR'S TOOL. LUTRONIC PROVIDED CLINICAL TRAINING FOR THIS SYSTEM WITH OPERATIONAL AND TREATMENT MATERIALS, INSERVICE TRAINING, AS WELL AS COMPLIMENTARY TRAINING WHICH THE PHYSICIAN DID NOT ATTENDED. LUTRONIC REVIEWED THE ADVERSE EVENT AND HAS COME TO THE CONCLUSION THAT THIS IS IN ALL PROBABILITY OPERATOR ERROR. DOSE OR AMOUNT: 40000 TOTALENERGY, 300 PULSE ENERGY; FREQUENCY: 40 PULSE RATE; ROUTE: FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10037 ACCUSCULPT ACCUSCULPT GEX LUTRONIC CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other