BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROFILE

    MDR report key: 1615604 · Received February 16, 2010

    Report

    Report Number
    2953696-2010-00008
    Event Type
    Other
    Date Received
    February 16, 2010
    Date of Event
    October 13, 2008
    Report Date
    October 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SCITON CONTACTED THE ADMINISTRATOR WHO PRESENTED THIS COMPLAINT ON (B)(6) 2008. THE PRIMARY CONCERN WAS THE WAY IN WHICH THE TRAINING WAS CONDUCTED AND THE ADMINISTRATOR REQUESTED THAT WE CONSIDER ALTERNATE CLINICAL TRAINER FOR THEIR PRACTICE SHOULD THEY REQUIRE TRAINING IN THE FUTURE. THE USER INDICATED THAT THEY ARE SATISFIED WITH THEIR PROFILE BBLS. 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 PT, WHO IS ALSO A STAFF MEMBER AT THIS PRACTICE, REPORTEDLY DEVELOPED BLISTERED AREAS SHORTLY AFTER A TREATMENT DURING A TRAINING SESSION FOR PROFILE BBLS CONDUCTED BY SCITON'S CLINICAL STAFF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA