BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAPULSE 5000C 208V

    MDR report key: 85588 · Received April 18, 1997

    Report

    Report Number
    2914019-1997-00014
    Event Type
    Other
    Date Received
    April 18, 1997
    Date of Event
    November 5, 1996
    Report Date
    April 10, 1997
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST OCCURRENCE OF REACTIVATION OF ACNE THAT HAS BEEN REPORTED TO CO. THIS IS NOT FROM A MALFUNCTION OF THE LASER OR USER ERROR, BUT DUE TO THE PATIENT'S PARTICULAR SKIN PHYSIOLOGY. INFORMATION FOR "EXPECTED SEQUELAE" HAS BEEN ADDED TO THE OPERATORS MANUAL.

    Description of Event or Problem · 1

    POST-OP RECURRENCE/REACTIVATION OF ACNE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPULSE 5000C 208V SURGICAL LASERS GEX COHERENT MEDICAL GROUP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other