BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCOTCHBOND UNIVERSAL ADHESIVE

    MDR report key: 5115091 · Received September 30, 2015

    Report

    Report Number
    9611385-2015-00032
    Event Type
    Injury
    Date Received
    September 30, 2015
    Report Date
    August 27, 2015
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    KLE
    PMA / PMN Number
    K110302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MANUFACTURER REPORTS ARE BEING SUBMITTED. MANUFACTURER REPORT NUMBERS 3005174370-2015-00069 AND 9611385-2015-00031, DESCRIBE THE FIRST AND SECOND DEVICE, RESPECTIVELY.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A DENTIST REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT REQUIRES ENDODONTIC TREATMENT OF TOOTH #4. THIS TOOTH HAD A CROWN MADE FROM 3M (B)(4) LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC, WHICH WAS SEATED WITH 3M (B)(4) RELYX ULTIMATE CEMENT AND 3M (B)(4) SCOTCHBOND UNIVERSAL ADHESIVE ON (B)(6) 2013. THE CROWN DEBONDED ON (B)(6) 2015, AND THE PATIENT REPORTED TEMPERATURE AND PRESSURE SENSITIVITY. THE PATIENT IS SCHEDULED FOR ENDODONTIC TREATMENT ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643599 SCOTCHBOND UNIVERSAL ADHESIVE AGENT, TOOTH BONDING, RESIN KLE 3M DEUTSCHLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention