BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAPULSE 5000 117V

    MDR report key: 94966 · Received May 29, 1997

    Report

    Report Number
    2914019-1997-00017
    Event Type
    Other
    Date Received
    May 29, 1997
    Date of Event
    March 6, 1997
    Report Date
    May 28, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN HAD PERFORMED PERIORBITAL AND PERIORAL RESURFACING ON A PT WHO HAS SHOWN ABNORMAL PIGMENTATION. (HYPERPIGMENTATION) PHYSICIAN STATED THAT THE LASER FUNCTIONED PROPERLY THROUGHOUT THE CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other