BEUDAMED
    FDA Adverse Event Summary report: N

    3M ESPE RELYX ULTIMATE

    MDR report key: 4182114 · Received October 8, 2014

    Report

    Report Number
    9611385-2014-00012
    Date Received
    October 8, 2014
    Date of Event
    April 9, 2014
    Report Date
    September 10, 2014
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    EMA
    PMA / PMN Number
    K110508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT APPEARS TO BE RELATED TO AN ALLERGIC REACTION TO THE DENTAL PRODUCTS. AN EPICUTANE TEST AGAINST THE PRODUCTS SHOWED A MILD REACTION AFTER 72 HOURS. THE 3M ESPE SCOTCHBOND UNIVERSAL AND 3M ESPE RELYX ULTIMATE HAVE BEEN ACCESSED FOR BIOCOMPATIBILITY AND HAVE BEEN FOUND TO BE SAFE FOR ITS INTENDED USE. THE FIRST SUSPECT MEDICAL DEVICE IS DESCRIBED IN MANUFACTURER REPORT NUMBER 9611385-2014-00011.

    Description of Event or Problem · 1

    ON (B)(6) 2014, 3M ESPE WAS CONTACTED BY A DENTIST WHO REPORTED THAT FOLLOWING USAGE OF THE 3M ESPE PRODUCTS 3M ESPE SCOTCHBOND UNIVERSAL AND 3M ESPE RELYX ULTIMATE, A FEMALE PATIENTS REQUIRED ENDODONTIC TREATMENT TO ADDRESS SENSITIVITY. THE DENTAL TREATMENT WAS DONE ON (B)(6) 2014. SUBSEQUENTLY FIVE TEETH WERE TREPANED AND DEVITALIZED (ONE TOOTH AT POSITION 34 ON (B)(6) 2014, THREE TEETH AT POSITIONS 42, 41, 33 ON (B)(6) 2014. AND ONE TOOTH AT POSITION 31 ON (B)(6) 2014).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630676 3M ESPE RELYX ULTIMATE CEMENT, DENTAL EMA 3M DEUTSCHLAND GMBH 512586

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R