BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCOTCHBOND UNIVERSAL

    MDR report key: 5102069 · Received September 24, 2015

    Report

    Report Number
    9611385-2015-00030
    Event Type
    Injury
    Date Received
    September 24, 2015
    Report Date
    August 26, 2015
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    KLE
    PMA / PMN Number
    K110302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE 3M ESPE RECEIVED THIS REPORT ON AUGUST 26, 2015 AND HAS ATTEMPTED TO OBTAIN MORE PATIENT-SPECIFIC INFORMATION. SINCE THE DENTIST WAS NOT ABLE TO PROVIDE THE ADDITIONAL INFORMATION, PATIENT-SPECIFIC REPORTING IS NOT POSSIBLE. SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MANUFACTURER REPORTS ARE BEING SUBMITTED. SECTION OF THIS REPORT DESCRIBES THE THIRD DEVICE. SECTION OF MANUFACTURER REPORT NUMBERS 3005174370-2015-00066 AND 3005174370-2015-00067, DESCRIBE THE FIRST AND SECOND DEVICE, RESPECTIVELY.

    Description of Event or Problem · 1

    ON (B)(6) 2015, DENTIST ADVISED 3M ESPE THAT THREE OR FOUR OF HER PATIENTS REQUIRED ENDODONTIC TREATMENT BECAUSE OF SEVERE SENSITIVITY. THE SENSITIVITY FOLLOWED RESTORATIVE TREATMENT USING 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE, 3M ESPE SCOTCHBOND ETCHANT AND 3M ESPE FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE. BECAUSE THE DENTIST WAS UNABLE TO PROVIDE PATIENT-SPECIFIC INFORMATION, THIS REPORT IS BEING COLLECTIVELY MADE FOR ALL FOUR PATIENTS. AFTER THE ENDODONTIC TREATMENT, THE SENSITIVITY RESOLVED IN ALL OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630733 SCOTCHBOND UNIVERSAL AGENT, TOOTH BONDING, RESIN KLE 3M DEUTSCHLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention