BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXCEL 1064NM ND: YAG LASER

    MDR report key: 2130687 · Received June 2, 2011

    Report

    Report Number
    2954354-2011-00008
    Event Type
    Other
    Date Received
    June 2, 2011
    Date of Event
    August 11, 2007
    Report Date
    May 27, 2011
    Manufacturer
    CUTERA
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LASER UNIT WAS SERVICED ON (B)(4) 2007 BY CUTERA FIELD SVC ENGINEER. THERE WAS A NEW EXCEL HANDPIECE INSTALLED AND CALIBRATED. ENERGY OUTPUT MEASUREMENTS WITHIN CUTERA SPECS. THE TREATMENT WAS PERFORMED ON OR AROUND (B)(6) 2007. THERE WAS NOT AN ADVERSE EVENT REPORTED TO CUTERA ON OR AROUND (B)(6) 2007 BY THE ACCOUNT. THE AESTHETICIAN AND MARKETING MGR ARE NO LONGER EMPLOYED BY THE TREATMENT PROVIDER. PT AND TREATMENT INFO WAS NOT AVAILABLE. THE PT CHARTS HAVE BEEN "SHREDDED" ACCORDING TO PERSON THAT REPORTED THE ADVERSE EVENT. THE NEXT SVC CALL WAS DATED FOR (B)(6) 2007. THIS EVENT WAS NOT REPORTED TO CUTERA UNTIL 4/28/2011.

    Description of Event or Problem · 1

    AESTHETICIAN HAD RECEIVED A LETTER FROM A LAWYER WITH COMPLAINT THAT PT (B)(6) HAD SUSTAINED A "BURN AND SCAR" AFTER LASER HAIR REDUCTION TREATMENT. THE LETTER STATED THAT THE TREATMENT WAS "ON OR ABOUT (B)(6) 2007."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other