BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRCS

    MDR report key: 1033063 · Received April 21, 2008

    Report

    Report Number
    2416455-2008-00001
    Event Type
    Other
    Date Received
    April 21, 2008
    Date of Event
    May 1, 2006
    Report Date
    April 17, 2008
    Manufacturer
    COLTENE/WHALEDENT INC.
    Product Code
    EMA
    PMA / PMN Number
    K810026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PATIENT CLAIMS CRCS CAUSED SERIOUS HEALTH PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRCS CEMENT, DENTAL EMA COLTENE/WHALEDENT INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other GUTTA PERCHA POINTS