BEUDAMED
    FDA Adverse Event Summary report: N

    EM ESPE SCOTCHBOND UNIVERSAL

    MDR report key: 3841325 · Received May 15, 2014

    Report

    Report Number
    3005174370-2014-00014
    Date Received
    May 15, 2014
    Report Date
    April 14, 2014
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    KLE
    PMA / PMN Number
    K110302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE THREE SUSPECT DEVICES INVOLVED IN THIS EVENT. THIS REPORT DESCRIES THE FIRST SUSPECT DEVICE. MANUFACTURER REPORTS NUMBERS 3005174370-2013-00013 AND 3005174370-2013-00015 PROVIDE INFO ON THE SECOND AND THIRD SUSPECT DEVICES INVOLVED IN THIS EVENT, RESPECTFULLY.

    Description of Event or Problem · 1

    ON (B)(6) 2014, 3M ESPE WAS CONTACTED BY A DENTIST WHO REPORTED THAT FOLLOWING PLACEMENT OF 3M ESPE LAVA ULTIMATE CROWS, THREE PATIENTS REQUIRED ENDODONTIC TREATMENT TO ADDRESS SENSITIVITY: ALSO USED ON THE CROWN PLACEMENT PROCEDURE WERE 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE AND 3M ESPE RELYX ULTIMATE CEMENT. THE ADHESIVE WAS NOT LIGHT CURED PRIOR TO PLACEMENT OF THE CROWN/CEMENT IN THESE PATIENTS. FOLLOWING ENDODONTIC TREATMENT, THE CROWS WERE REPLACED WITH ALTERNATE PRODUCTS AND THE PTS ARE REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289904 EM ESPE SCOTCHBOND UNIVERSAL AGENT, TOOTH BONDING, RESIN KLE 3M DEUTSCHLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention