BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTILINK AUTOMIX

    MDR report key: 2074983 · Received March 25, 2011

    Report

    Report Number
    9612352-2011-00004
    Event Type
    Other
    Date Received
    March 25, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 24, 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
    MA, US
    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. PATIENT REQUIRED ENDODONTIC TREATMENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTILINK AUTOMIX DENTAL CEMENT EMA IVOCLAR VIVADENT AG 627473AN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other