BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M ESPE STAINLESS STEEL CROWN, PRIMARY MOLAR

    MDR report key: 2919726 · Received January 14, 2013

    Report

    Report Number
    3005174370-2013-00001
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    August 22, 2012
    Report Date
    December 14, 2012
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    ELZ
    PMA / PMN Number
    EXCEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED TO 3M ESPE THAT A CHILD WAS HOSPITALIZED AFTER THE CHILD HAD RECEIVED DENTAL TREATMENT, WHICH INCLUDED A 3M(TM) ESPE(TM) PRIMARY STAINLESS STEEL CROWN (MOLAR). THE PLACEMENT OF THE CROWN TOOK PLACE ON (B)(6) 2012. FOLLOWING PLACEMENT OF THE CROWN, THE CHILD DEVELOPED A FEVER AND CHILLS. IN ADDITION, THE PALATE WAS INFLAMED WITH WHITE SPOTS. THE CHILD WAS TAKEN TO A HOSPITAL FOR TREATMENT, DETAILS OF WHICH WERE NOT MADE AVAILABLE TO 3M ESPE. THE TESTS FOR THE CAUSE OF THIS REACTION ARE ONGOING; THE CHILD'S CONDITION IS REPORTED AS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20147 3M ESPE STAINLESS STEEL CROWN, PRIMARY MOLAR CROWN, PREFORMED ELZ 3M ESPE DENTAL PRODUCTS ND- 96

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization