BEUDAMED
    FDA Adverse Event Summary report: N

    3M ESPE RELYX UNICEM 2 AUTOMIX

    MDR report key: 4222954 · Received October 28, 2014

    Report

    Report Number
    9611385-2014-00013
    Date Received
    October 28, 2014
    Report Date
    October 1, 2014
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    EMA
    PMA / PMN Number
    K100756
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATA ON THE SYMPTOMS WHICH LED TO THE NECESSITY OF THE ROOT CANAL TREATMENTS WERE NOT GIVEN BY THE DENTIST. THE FACTS THAT THE PROBLEMS OCCURRED IN THREE DIFFERENT PTS AND NO OTHER COMPLAINTS HAVE REACHED US REGARDING THE AFFECTED LOT-NO 551668 MAKES IT DOUBTABLE THAT THERE ARE UNDERLYING ALLERGIC REACTIONS OR MATERIAL DEFECTS. AS IT WASN'T POSSIBLE TO GATHER MORE INFO FROM THE DOCTOR'S OFFICE UNTIL THE TIME OF THIS REPORT, IT CAN'T BE DETERMINED IF A HANDLING ERROR WAS THE REASON FOR THE ADVERSE EVENTS. 3M ESPE RELYX UNICEM 2 AUTOMIX HAS BEEN ASSESSED FOR BIOCOMPATIBILITY AND HAS BEEN FOUND TO BE SAFE FOR ITS INTENDED USE.

    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 PRODUCT, 3M ESPE RELYX UNICEM 2 AUTOMIX. THREE PTS REQUIRED ENDODONTIC TREATMENT. TWO PTS HAD ROOT CANAL TREATMENTS BEFORE AND HAD TO HAVE THEM RE-DONE. NO OTHER PRODUCTS WERE USED ASIDE FROM 3M ESPE RELYX UNICEM 2 AUTOMIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689448 3M ESPE RELYX UNICEM 2 AUTOMIX CEMENT, DENTAL EMA 3M DEUTSCHLAND GMBH 551668

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R