BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCITON JOULE

    MDR report key: 8883560 · Received August 9, 2019

    Report

    Report Number
    MW5088951
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    July 17, 2019
    Report Date
    August 7, 2019
    Manufacturer
    SCITON, INC.
    Product Code
    GEX
    UDI-DI
    00863249000305
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A BBL TREATMENT WITH THE SCITON JOULE, APPROPRIATE SETTING AND SHE HAD FIRST AND SECOND DEGREE BURNS TO HER CHEST AND NECK. A TEST SPOT WAS DONE. THE RECOMMENDATIONS IN THE MANUAL WERE FOLLOWED BUT WERE NOT CLEAR ABOUT WHERE TO PUT THE GEL ON THE DEVICE. THE DEVICE WAS THEN CHECKED BY THE MFR'S SERVICE STAFF AND FOUND TO BE OKAY AND SAID USE A LARGE AMOUNT OF GEL ON THE SAPPHIRE TIP AND THE SNAP ON ADAPTER. THIS DIFFERS FROM THE MANUAL RECOMMENDATIONS AND THE CONTAINER FOR THE SNAP ON ADAPTER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672005 SCITON JOULE POWER LASER SURGICAL INSTRUMENT GEX SCITON, INC. JOULE 00863249000305

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R