BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCOTCHBOND UNIVERSAL ADHESIVE

    MDR report key: 4995013 · Received August 6, 2015

    Report

    Report Number
    9611385-2015-00007
    Event Type
    Injury
    Date Received
    August 6, 2015
    Report Date
    July 9, 2015
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    KLE
    PMA / PMN Number
    K110302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE 3M ESPE RECEIVED THIS REPORT ON JUNE 24, 2015, AND HAS ATTEMPTED TO OBTAIN MORE SPECIFIC INFO. HOWEVER, BECAUSE THE REPORTED EVENTS HAPPENED SOMETIME BETWEEN 2011 AND 2015 AND BECAUSE THE DENTIST WAS NOT WILLING OR ABLE TO PROVIDE ADD'L INFO, PT-SPECIFIC REPORTING IS NOT POSSIBLE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A DENTIST REPORTED THAT SOME OF HIS PTS HAD NEED FOR ENDODONTIC TREATMENT. THESE PTS HAD DENTAL RESTORATIONS MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D, WHICH WERE SEATED WITH 3M ESPE RELX ULTIMATE CEMENT AND 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE. THE REPORTING DENTIST INDICATED THAT APPROX 240 OF HIS PTS EXPERIENCED SENSITIVITY. THE DENTIST WAS UNABLE TO PROVIDE A NUMBER FOR THOSE REQUIRING ENDODONTIC TREATMENT BECAUSE THE EVENTS OCCURRED OVER A PERIOD OF SEVERAL YEARS (2011 TO 2015). SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MFR REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE FIRST DEVICE. MFR REPORT NUMBERS 3005174370-2015-00046 AND 9611385-2015-00006, DESCRIBE THE FIRST AND SECOND DEVICE, RESPECTFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520956 SCOTCHBOND UNIVERSAL ADHESIVE AGENT, TOOTH BONDING, RESIN KLE 3M DEUTSCHLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other