BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMDOGAIN

    MDR report key: 574068 · Received February 18, 2005

    Report

    Report Number
    1222315-2005-00001
    Event Type
    Death
    Date Received
    February 18, 2005
    Date of Event
    January 14, 2005
    Manufacturer
    BIORA AB
    Product Code
    NQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE INITIAL INFORMATION RECEIVED REPORTED THAT A PT DIED 2 DAYS AFTER PERIO SURGERY DURING WHICH EMDOGAIN WAS USED. THE DENTIST STATED THAT THIS EVENT HAD NOTHING TO DO WITH THE PERIO SURGERY OR EMDOGAIN. THE DENTIST HAD TREATED THIS PT 3 TIMES SURGICALLY PRIOR (THIS WAS THE FIRST TIME EMDOGAIN WAS USED). THE PT WAS SUSPECTED TO HAVE A CONDITION CALLED DIC. IN THIS CONDITION PLATELETS BREAK DOWN RAPIDLY PROFUSE BLEEDING CAN OCCUR. AN AUTOPSY WILL BE PERFORMED. THE DENTIST DID PRESCRIBE AMOXICILLIN AND IBUPROFEN. OTHER MEDICATIONS UNKNOWN. THE CLINICIAN LATER SPOKE TO THE MEDICAL EXAMINER AND LEARNED THAT IT APPEARS THAT THE PT HAD AN AUTOIMMUNE PROBLEM. THEY NO LONGER SUSPECT DIC SINCE THE PT HAD BLEEDING AROUND THE HEART AND LUNGS AND NOT AT THE SURGICAL SITE. WITH DIC THEY WOULD HAVE EXPECTED BLEEDING AT THE SURGICAL SITE. THE CLINICIAN STILL ANTICIPATE THAT HE WILL RECEIVE A COPY OF THE AUTOPSY REPORT, HOWEVER THIS WILL TAKE ANOTHER 6-8 WEEKS. THE MEDICAL EXAMINER DID NOT SEEM CONCERNED ABOUT EMDOGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMDOGAIN ENAMEL MATRIX DERIVATIVE NQA BIORA AB NA 1033

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death POST SURGERY: AMOXICILLIN AND IBUPROFEN.