BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPULSE CO2 LASER

    MDR report key: 64605 · Received January 24, 1997

    Report

    Report Number
    MW1010611
    Event Type
    Injury
    Date Received
    January 24, 1997
    Date of Event
    June 6, 1996
    Report Date
    January 20, 1997
    Manufacturer
    COHERANT, INC. MEDICAL GRP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NON HEALING EXUDATIVE DERMATITIS OF FACE. NO DEFINITE ETIOLOGY DETERMINED. UNABLE AND FIND SIMILAR RPOBLEM REPORTED IN LITERATURE. OTHER PROBLEM BY VERBAL COMMUNICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPULSE CO2 LASER CO 2 LASER GEX COHERANT, INC. MEDICAL GRP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention