BEUDAMED
    FDA Adverse Event Summary report: N

    2954354-2014-00001

    MDR report key: 3832301 · Received January 14, 2014

    Report

    Report Number
    2954354-2014-00001
    Date Received
    January 14, 2014
    Report Date
    December 17, 2013
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUTERA RECEIVED FROM FDA - (DIVISION OF POST MARKET SURVEILLANCE REPORT) MW5032279 THAT WAS SUBMITTED THROUGH THE FDA'S MEDWATCH PROGRAM. THE IDENTITY OF THE PERSON THAT SUBMITTED THE REPORT IS UNKNOWN. THE LOCATION OF WHERE THE PERSON RECEIVED THE 2 IPL PROCEDURES IS UNKNOWN. THE REPORT ALLEGES THAT THE PROCEDURES CAUSED "FAT LOSS AND PREMATURE AGING; DARK CIRCLES, SAGGING SKIN, HOLLOW EYES AND HUGE PATCHES OF MELASMA". THESE REPORTED SYMPTOMS ARE NOT KNOWN SIDE EFFECTS ASSOCIATED WITH ANY OF CUTERA MEDICAL DEVICES. CUTERA IS UNABLE TO CONTACT THE DEVICE OWNER/OPERATOR FOR FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36296 GEX CUTERA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other