BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRAUMANN EMGOGAIN

    MDR report key: 3227290 · Received July 11, 2013

    Report

    Report Number
    1222315-2013-00003
    Event Type
    Other
    Date Received
    July 11, 2013
    Date of Event
    June 2, 2013
    Report Date
    July 11, 2013
    Manufacturer
    BIORA AB,
    Product Code
    NQA
    PMA / PMN Number
    P930021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE RISK MANAGEMENT REPORT "RISK MGMT REPORT_EMDOGAIN_PREFGEL_V3" CONFIRM THAT THE USE ON PTS SHOWING PREVIOUS SENSITIZATION TO EMDOGAIN IS ASSESSED AND REFLECTED IN THE IFU LABELLING 700019 STRAUMANN EMDOGAIN (US VERSION). THIS LABELLING STATES UNDER: WARNING: IMMUNOLOGICAL STUDIES SUGGEST THAT A SMALL NUMBER OF PTS MAY BECOME SENSITIZED TO EMDOGAIN AS A RESULT OF REPEATED USE. PLEASE SEE CAUTION IN PTS PREDISPOSED TO ALLERGIC REACTIONS AND FOLLOW PTS RECEIVING REPEATED USE CLOSELY. POST-MARKET EXPERIENCE HAS INDICTED THAT THE SENSITIZATION ADVERSE REACTION RATE IS LOW. REQUIRED TREATMENT HAS RANGED FROM NO INTERVENTION NEEDED TO ANALGESICS AND/OR ANTIHISTAMINES." PRECAUTIONS: CLINICAL AND RADIOGRAPHIC EVAL SHOULD BE PREFORMED BEFORE TREATMENT. THE REVIEW OF THE COMPLAINTS DATABASE CONFIRMS THAT NO FURTHER SIMILAR COMPLAINTS WITH THESE ARTICLE AND LOT NUMBERS HAVE BEEN REGISTERED. THE MFR REVIEWED MFG BATCH RECORDS FOR BOTH 075.113 LOT FK781 AND 075.113 LOT FH765 AND CONFIRMS THAT THE PRODUCT WAS RELEASED ACCORDING TO SPEC. A PREVIOUS EVALUATION BY AN ALLERGIST STATES THAT THE ALLERGY POTENTIAL OF EMDOGAIN IS VERY LOW.

    Description of Event or Problem · 1

    CLINICIAN REPORTS THAT HE CARRIED OUT A CONNECTIVE TISSUE GRAFT (AUTOGENOUS) + CAF ON A PT USING EMDOGAIN (075.113 LOT FK781). ABOUT 3 DAYS POST OP THERE WAS ABNORMAL SWELLING. THIS EVENT IS REPORTED TO HAVE HAPPENED ON (B)(6) 2013. THE CLINICIAN RE-FLAPPED AND RE-APPLIED EMDOGAIN (075.113 LOT FH765) AND HAD SWELLING AGAIN. THIS EVENT IS REPORTED TO HAVE HAPPENED ON (B)(6) 2013. HE REPORTS POSSIBLE ALLERGIC REACTION. HE IS GOING TO EXPLORE ANY ALLERGIES THAT THE PT MIGHT HAVE AND PUT HER ON ANTIHISTAMINES. ADD'L INFO PROVIDED BY THE CLINICIAN ON (B)(6) 2013 STATES THAT THE SWELLING AND TISSUE DEHISCENCE HAS PERSISTED FOR TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320820 STRAUMANN EMGOGAIN BIOLOGIC MATERIAL, DENTAL NQA BIORA AB, FK781

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other GUT SUTURED| PERIO DRESSING FIRST TIME, NOT SECOND.| PREGEL