BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROFILE

    MDR report key: 1615603 · Received February 16, 2010

    Report

    Report Number
    2953696-2010-00007
    Event Type
    Other
    Date Received
    February 16, 2010
    Date of Event
    November 14, 2008
    Report Date
    November 17, 2008
    Manufacturer
    SCITON, INC.
    Product Code
    GEX
    PMA / PMN Number
    070388
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A WRONG BBL FILTER WAS MISTAKENLY USED ON A PT. THE PHYSICIAN USED A 515 NM BBL FILTER TO TREAT VESSELS INSTEAD OF USING A 560 NM BBL FILTER AS INSTRUCTED IN THE OPERATOR MANUAL. NO MALFUNCTION OF THIS DEVICE WAS REPORTED WITH THIS EVENT. THE PHYSICIAN'S OFFICE RECEIVED CLINICAL TRAINING FROM SCITON'S CLINICAL STAFF AND NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED SINCE THIS TRAINING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(4) TYPE II PT DEVELOPED PURPURA (AND SIGNIFICANT ERYTHEMA) OF THE UPPER CHEEK/MALAR AREA AFTER BEING TREATED FOR DISTINCT VESSELS AND FLUSHING OF TOP OF NOSE & CHEEKS WITH A WRONG BBL FILTER. A 560 NM FILTER SHOULD HAVE BEEN USED FOR THIS VASCULAR APPLICATION AS INSTRUCTED IN THE OPERATOR MANUAL INSTEAD OF 515 NM FILTER.

    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