BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTILINK AUTOMIX

    MDR report key: 2255165 · Received August 8, 2011

    Report

    Report Number
    9612352-2011-00007
    Event Type
    Other
    Date Received
    August 8, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 5, 2011
    Manufacturer
    IVOCLAR VIVADENT AG
    Product Code
    EMA
    PMA / PMN Number
    K032470
    Removal / Correction Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AFTER CEMENTING RESTORATIONS WITH MULTILINK AUTOMIX, POST OPERATIVE SENSITIVITIES OCCURRED. PT REQUIRED ENDODONTIC TREATMENT. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTILINK AUTOMIX DENTAL CEMENT EMA IVOCLAR VIVADENT AG 627471AN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other