BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN XL

    MDR report key: 1810765 · Received August 16, 2010

    Report

    Report Number
    MW5017131
    Event Type
    Injury
    Date Received
    August 16, 2010
    Report Date
    August 16, 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

    TREATMENT PROVIDER STATED THAT TITAN XL HANDPIECE HAD CAUSED A BURN. TREATMENT PROVIDER REFUSED TO GIVE ANY TREATMENT INFORMATION. TREATMENT PROVIDER REFUSED TO RETURN THE TITAN XL HANDPIECES BACK TO CUTERA AS REQUIRED BY FDA CLASS II RECALL. DATES OF USE: (B)(6) 2008 -- (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