BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAPULSE

    MDR report key: 89925 · Received May 6, 1997

    Report

    Report Number
    2914019-1997-00016
    Event Type
    Other
    Date Received
    May 6, 1997
    Date of Event
    September 4, 1996
    Report Date
    May 6, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SKIN RESURFACING - THE ENTIRE FACE WAS DONE WHICH RESULTED IN SCARRING. CONTINUED REDNESS OF THE FACE TO THIS DATE. MASSIVE INFECTION FOLLOWING PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention