BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMDOGAIN

    MDR report key: 1604498 · Received February 5, 2010

    Report

    Report Number
    1222315-2010-00005
    Event Type
    Injury
    Date Received
    February 5, 2010
    Report Date
    February 5, 2010
    Manufacturer
    BIORA AB
    Product Code
    NQA
    PMA / PMN Number
    P930021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SYMPTOMS AND TESTS/ADDITIONAL CLINICIAN VISITS WERE REPORTED TO THE TREATING CLINICIAN BY THE PT. INITIAL PRODUCT USE WAS ON (B) (6) 2009, ON THE RIGHT SIDE OF MOUTH. THE CLINICIAN WAS CONTACTED FOR ADDITIONAL INFO. CLINICIAN REPORTS THAT THE PT WAS REFERRED TO THE CLINICIAN FOR PAIN. PT REPORTED PAIN ON THE DAY OF SURGERY. FOLLOW UP VISIT BY THE CLINICIAN ON (B) (6) 2009, REVEALED THE SITE LOOKED FINE LOCALLY. NO CONCERNS REGARDING THE USE OF THE PRODUCT WAS RAISED TO THE CLINICIAN BY THE PT AT THIS VISIT. ALTHOUGH REQUESTED, NO RESULTS FROM TESTS HAVE BEEN PROVIDED TO THE CLINICIAN. NO KNOWN DIAGNOSIS HAS BEEN COMMUNICATED. PT FAILED TO APPEAR FOR SUBSEQUENT FOLLOW UP APPOINTMENT. CLINICIAN REPORTS THAT SHE HAS NEVER SEEN ANYTHING LIKE THIS BEFORE AND HAS USED THE PRODUCT FOR YRS. MFR REVIEW OF CONCOMITANT MEDICINES INDICATE THAT SOME OF THESE SYMPTOMS ARE IDENTIFIED IN PRODUCT LABELING FOR THOSE MEDICINES. MFR REVIEWED MFG BATCH RECORDS AND NO DISCREPANCIES WERE FOUND. NO OTHER SIMILAR REPORTS HAVE BEEN FILED.

    Description of Event or Problem · 1

    PT REPORTS A NUMBER OF COMPLAINTS OVER A PERIOD OF SEVERAL MONTHS THAT INCLUDE SWELLING AND SORENESS IN JAW, STIFFNESS, TIGHTNESS, ITCHING, ARM AND LEG PAIN, DISCOMFORT, SHOOTING PAIN, PRESSURE IN HEAD, STIFF NECK, SWELLING AND TENDERNESS OF CAROTID ARTERY, PULSING IN EAR, WEAKNESS AND NUMBNESS, HEAT IN EARS AND HEAD, UNABLE TO SPEAK NORMALLY, SUNBURN FEELING, NEED TO CLEAR THROAT, GRAVELLY VOICE, A "STRING UNDER SKIN IS GLIDING OVER MY LEFT SHOULDER WHILE STRETCHING", EYES BLOODSHOT UPON WAKING. AFTER PHYSICAL THERAPY, ARM FEELS LIKE IT WILL FALL OFF, CRYING WITH "THICK TEARS", INTERRUPTED SLEEP WITH CONGESTION. DULL ACHE AND "STRING FLOATING ACROSS BACK/RIGHT SHOULDER BLADE. TOUCHING STRING MAKES RIGHT SINUS CLEAR." FINDS NECK MASS THAT GOES AWAY 20 MINUTES AFTER TAKING AMOXICILLIN. "PRESSURE EVENTS" OCCURRING. THICK SALIVA/MUCOUS IN MOUTH, FULLNESS IN HEAD. NIGHT SWEATS. REPORTS OF PAIN IN BOTH LEFT AND RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMDOGAIN BIOLOGIC MATERIAL, DENTAL NQA BIORA AB H0933

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention APAP| AZITHRIMYCIN| HYDROCODONE| IBUPROFEN| CHLORHEXADINE GLUCONATE SOLUTION| DEXAMETHASONE