BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROFILE

    MDR report key: 1615605 · Received February 16, 2010

    Report

    Report Number
    2953696-2010-00009
    Event Type
    Other
    Date Received
    February 16, 2010
    Date of Event
    May 15, 2009
    Report Date
    May 18, 2009
    Manufacturer
    SCITON, INC.
    Product Code
    GEX
    PMA / PMN Number
    070388
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SCITON CLINICAL STAFF CONCLUDED THAT THE PROBABLE ROOT CAUSE FOR THIS ADVERSE EVENT WAS MISTAKENLY PROVIDING TREATMENT WITH 420 AND 560 FILTERS IN THIS FITZPATRICK TYPE V PT. SCITON RECOMMENDS THAT ONLY THE 590 NM FILTER WITH 6 PASSES SHOULD BE USED ON SKIN TYPE V PTS. THERE IS NO EVIDENCE THAT THERE WAS A DEVICE MALFUNCTION. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED BY THIS PRACTICE.

    Description of Event or Problem · 1

    A CLINICIAN PERFORMED A BBL ACNE TREATMENT ON A FITZPATRICK TYPE V PT AND REPORTED RECEIVING A CALL FROM A PT WHO REPORTED BLISTERING WITHIN 12 HOURS OF TREATMENT. THE PT WAS TREATED FOR THE FIRST TIME WITH THE FOLLOWING BBL ACNE PROTOCOL PARAMETERS: 420 FILTER, 4 J/CM2, 200 MS, 15 DEG C, 2 PASSES, 560 FILTER, 15 J/CM2, 200 MS, 15 DEG C, 1.5 PASES WITH PT COMPLAINING OF "BURNING SENSATION." A 590 FILTER, 15 J/CM2, 200 MS, 15 DEG C, 6 PASSES. THE CLINICIAN DID NOT QUESTION THE FUNCTION OF THE BBL HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE BBL GEX SCITON, INC. PROFILE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA