BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASER GENESIS 1064NM ND: YAG LASER

    MDR report key: 2920239 · Received October 19, 2012

    Report

    Report Number
    2954354-2012-00017
    Event Type
    Other
    Date Received
    October 19, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 19, 2012
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K023954
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY STATED THAT THE DEVICE DID NOT MALFUNCTION. THE DEVICE PERFORMED AS INTENDED. THE PATIENT CONTACTED THE MANUFACTURER ON (B)(6) 2012 AND REPORTED A "PUSTULAR OUTBREAK ON THE NOSE". THE TREATMENT WAS PERFORMED ON NOSE AND CHEEKS. THE PATIENT DID NOT REPORT ANY ISSUES ON THE CHEEKS. THE PATIENT DID NOT REPORT ANY ISSUES ON THE CHEEKS. THE PATIENT DID NOT REPORT "SCARRING" OR "ORANGE PEEL SKIN" TO THE MANUFACTURER. THE DEVICE USER FACILITY STATED THAT THE PATIENT CANCELLED A FOLLOW UP APPOINTMENT DUE TO IMPROVEMENT IN THE REPORTED SYMPTOMS.

    Description of Event or Problem · 1

    THIS REPORT IS IN RESPONSE TO MEDWATCH REPORT (B)(6) SUBMITTED BY THE PATIENT THAT RECEIVED THE LASER GENESIS TREATMENT OF REDNESS ASSOCIATED WITH ROSACEA. THE PATIENT REPORTED TO THE MANUFACTURER THAT THE PATIENT EXPERIENCED "A PUSTULAR OUTBREAK" ON THE NOSE THE NEXT DAY AFTER THE PROCEDURE. THE MANUFACTURER CONTACTED THE USER FACILITY, THE USER FACILITY REPORTED THAT THE PATIENT EXPERIENCED AND EXACERBATION OF THE PRE-EXISTING CONDITION OF ROSACEA. HEAT IS A KNOWN ROSACEA "TRIGGER". ROSACEA (ACNE ROSACEA) IS A PERSISTENT SKIN DISORDER THAT PRODUCES REDNESS, TINY PIMPLES, AND NOTICEABLE BLOOD VESSELS, USUALLY ON THE CENTRAL AREA OF THE FACE. THE CAUSE IS UNKNOWN. TYPICAL SYMPTOMS INCLUDE REDNESS, SMALL VISIBLE BLOOD VESSELS, AND SMALL PIMPLES THAT APPEAR ON THE CHEEKS AND NOSE. ((B)(4)). THE DEVICE USER STATED THE DEVICE PERFORMED AS INTENDED. THERE ARE NO ISSUES WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER GENESIS 1064NM ND: YAG LASER GEX CUTERA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR SUNBLOCK APPLIED IMMEDIATELY AFTER THE TREATMENT.