BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MI PASTE

    MDR report key: 5117881 · Received September 22, 2015

    Report

    Report Number
    1410097-2015-00004
    Event Type
    Injury
    Date Received
    September 22, 2015
    Date of Event
    August 19, 2015
    Report Date
    September 17, 2015
    Manufacturer
    GC CORP.
    Product Code
    EJR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    GC AMERICA RECEIVED A REPORT ON 08/24/2015 FROM (B)(4), FROM A SALES REPRESENTATIVE THAT MI PASTE WAS APPLIED TO A PATIENT WITH MILK ALLERGIES. THE REPORT STATED THAT PRIOR TO TREATMENT, THE PARENT REPORTED THAT THE PATIENT HAD AN ALLERGY TO MILK, BUT THE PRODUCT WAS STILL APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625576 MI PASTE PROPHY PASTE EJR GC CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other