BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRA PULSE 5000 117V

    MDR report key: 86868 · Received April 25, 1997

    Report

    Report Number
    2914019-1997-00015
    Event Type
    Other
    Date Received
    April 25, 1997
    Date of Event
    August 8, 1995
    Report Date
    April 25, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINT OF HYPERPIGMENTATION FROM A FACIAL RE-SURFACING DONE 1 1/2 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA PULSE 5000 117V CO2 LASERS GEX COHERENT MEDICAL LASER GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other