BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1064NM ND: YAG LASER

    MDR report key: 2210563 · Received August 10, 2011

    Report

    Report Number
    2954354-2011-00012
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 10, 2011
    Manufacturer
    CUTERA
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT AFTER EVALUATION BY THE TREATMENT PROVIDER. "PUZZLING ATROPHIC MACULES WITH ONSET 4 WEEKS FOLLOWING 1064NM LASER TREATMENT; WITH NO PRECEDING INFLAMMATORY PROCESS IN THE IMMEDIATE POST-TREATMENT PERIOD OR IMMEDIATELY PRECEDING THE FIRST OBSERVATION OF THE LESIONS. THE MECHANISM OR EXPLANATION FOR THESE IS NOT CLEAR. THE LESION ON THE LEFT CHEEK AND THE RESOLVED AREA OVER THE NASAL DORSUM HAVE A TIME COURSE THAT COULD BE RELATED TO THE LASER; THESE CONTINUE TO RESOLVE WELL. ALL LESIONS ARE EXPECTED TO IMPROVE WITH THE TINCTURE OF TIME AND I WOULD RECOMMEND NO INTERVENTION FOR AT LEAST 6 MONTHS. IMPROVEMENTS MAY CONTINUE UP TO 1 YEAR. IF ATROPHY DOES PERSIST CONSIDER THE USE OF HA FILLER OR CONSERVATIVE RESURFACING OR NONABLATIVE REMODELING." LATE ENTRY: PATIENT TELEPHONED TO REPORT SHE HAD SEEN HER PLASTIC SURGEON THAT DIAGNOSED: "SCAR FROM COLLAGEN CONTRACTION."

    Description of Event or Problem · 1

    "ATROPHIC MACULES WITH ONSET 4 WEEKS FOLLOWING 1064NM LASER TREATMENT - LEFT CHEEK AND X 2 ON THE NOSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other RETIN-A MICRO 0.1% CREAM| MINOCYLINE 100 MG| 15MSEC, 56 PULSES / LASER GENESIS: 15J/CM2| CLINDAMYCIN 1% LOTION| BENZOYL PEROXIDE| NORITATE CREAM| LASER VASCULAR TREATMENT: 3MM SPOT, 160J/CM2,