BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER GENESIS

    MDR report key: 3842917 · Received May 8, 2014

    Report

    Report Number
    2954354-2014-00002
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K023954
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE LASER WAS USED TO TREAT A DEPRESSED SCAR OVER THE NOSE. THE SCAR WAS A RESULT OF A PRIOR TRAUMATIC INJURY THAT MAY HAVE INCLUDED AN EMBEDDED FOREIGN OBJECT. THE TREATED AREA DEVELOPED FULL THICKNESS THERMAL INJURY REQUIRING MEDICAL INTERVENTION FOR WOUND CARE. THE LASER WAS EVALUATED AND THE ENERGY OUTPUT WAS FOUND TO BE LOW, BELOW SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278004 LASER GENESIS POWERED LASER SURGICAL INSTRUMENT GEX CUTERA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other