BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIMELIGHT

    MDR report key: 3231924 · Received November 21, 2012

    Report

    Report Number
    2954354-2012-00016
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    June 16, 2012
    Report Date
    November 15, 2012
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE USER FACILITY DID NOT REPORT THAT THE DEVICE WAS POTENTIALLY INVOLVED IN A PT EVENT. THE EVENT WAS REPORTED 5 MONTHS AFTER THE DATE OF THE PROCEDURE. THE ROOT CAUSE IS UNK DUE TO THE HANDPIECE BEING RECONDITIONED AND RETURNED TO STOCK. THE PT REC'D 3 PULSES OF LIGHT WITH THE DEVICE. THE REPORTED EVENT HAPPENED ON 1 PULSE. THE DEVICE WAS USED TO TREAT ANOTHER PT LATER ON THE SAME DAY WITH NO REPORTED ISSUE.

    Description of Event or Problem · 1

    THE PT EXPERIENCED A BURN TO UPPER LIP WITH THE DEVELOPMENT OF A SMALL SCAR. THE PT REC'D A STEROID INJECTION. THE USER FACILITY REPORTS THE SCAR IS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIMELIGHT GEX CUTERA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention