BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN XL

    MDR report key: 1726794 · Received June 14, 2010

    Report

    Report Number
    MW5016368
    Event Type
    Injury
    Date Received
    June 14, 2010
    Date of Event
    November 4, 2008
    Report Date
    June 14, 2010
    Manufacturer
    CUTERA
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT: CUSTOMER REPORT "POSSIBLE ADVERSE PT REACTION WHILE TREATING" USING TITAN. TREATMENT PROVIDER DID NOT SPECIFY THE "ADVERSE REACTION." PRODUCT PROBLEM: COATING FAILURE ON PARTS 3001120 / 3001121. ROUTE: TRANSDERMAL. DATES OF USE: (B) (6) 2006 - (B) (6) 2008. DIAGNOSIS OR REASON FOR USE: UNK. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    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