BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXODENT

    MDR report key: 2061352 · Received April 13, 2011

    Report

    Report Number
    MW5020275
    Event Type
    Injury
    Date Received
    April 13, 2011
    Product Code
    KOO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USE FIXODENT FROM 1999 TO (B)(6) 2011. DOSE OR AMOUNT: DENTURE CREAM, FREQUENCY: 3 TIMES A DAY, ROUTE: ORAL. DIAGNOSIS OR REASON FOR USE: HOLD TEETH IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXODENT DENTURE CREAM KOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S