BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN XL

    MDR report key: 1802798 · Received August 10, 2010

    Report

    Report Number
    MW5017068
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    March 24, 2010
    Report Date
    August 10, 2010
    Manufacturer
    CUTERA
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED BLISTER ON LEFT CHEEK. DOSE OR AMOUNT: 40J/CM2, ROUTE: TRANSDERMAL. DATES OF USE: (B)(6) 2007 - (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITAN XL TITAN GEX CUTERA TITAN XL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other