BEUDAMED
    FDA Adverse Event Other Summary report: N

    TITAN XL

    MDR report key: 2470740 · Received February 17, 2012

    Report

    Report Number
    2954354-2012-00008
    Event Type
    Other
    Date Received
    February 17, 2012
    Date of Event
    December 1, 2011
    Report Date
    February 21, 2012
    Manufacturer
    CUTERA, INC.
    Product Code
    ILY
    PMA / PMN Number
    K033768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY INITIALLY REPORTED THAT THE AREA WAS "HEALING WELL" AND DID NOT REQUIRE INTERVENTION. (B)(6) 2012, USER FACILITY REPORTED THAT PT REQUIRED MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    "FOUR - FIVE SMALL BLISTERS AFTER TITAN TREATMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITAN XL ILY OPTIONAL INFRARED HANDPIECE ILY CUTERA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention