BEUDAMED
    FDA Adverse Event Other Summary report: N

    EMDOGAIN

    MDR report key: 1943608 · Received December 13, 2010

    Report

    Report Number
    1222315-2010-00020
    Event Type
    Other
    Date Received
    December 13, 2010
    Report Date
    December 10, 2010
    Manufacturer
    BIORA AB
    Product Code
    NQA
    PMA / PMN Number
    P930021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED MANUFACTURING BATCH RECORDS AND NO DISCREPANCIES WERE FOUND. AN ALLERGY TEST IS BEING CONDUCTED AND THE MANUFACTURER EXPECTS TO BE MADE AWARE OF THE RESULTS.

    Description of Event or Problem · 1

    IMMEDIATELY AFTER SURGERY WITH EMDOGAIN AND PREFGEL, WHEN MAKING THE SUTURE, THE RIGHT PART OF THE PT'S FACE SWELLED FROM EYE DOWN TO THROAT. PT GOT AN INJECTION BY THE GENERAL DOCTOR AND NOW EVERYTHING IS OK. THE FACE IS NOT SWOLLEN ANYMORE AND THE PT IS WELL. IT IS NOT KNOWN WHICH OTHER PRODUCTS WERE USED IN CONJUNCTION WITH THIS SURGERY, E.G LOCAL ANESTHESIA, WHICH MORE OFTEN THAN EMDOGAIN TRIGGERS ALLERGIC REACTIONS. POSSIBLY, A SIMILAR PRODUCT THAT WAS USED 50 YEARS AGO AND THEN CAUSED THE SWELLING, ALSO CAUSED IT NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMDOGAIN BIOLOGIC MATERIAL, DENTAL NQA BIORA AB Z3144

    Patients

    Seq Age Sex Outcome Treatment
    1 Other