BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMDOGAIN 0.3 ML MULTI, USA

    MDR report key: 774304 · Received October 24, 2006

    Report

    Report Number
    1222315-2006-00002
    Event Type
    Injury
    Date Received
    October 24, 2006
    Date of Event
    February 2, 2006
    Report Date
    October 24, 2006
    Manufacturer
    BIORA AB
    Product Code
    NQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THROMBOCYTOPENIA OFTEN OCCURS AS A RESULT OF ANOTHER UNDERLYING DISEASE OR DISORDER, AND CAN BE A KNOWN SIDE EFFECT OF CERTAIN DRUGS SUCH AS DOXCYCLINE, WHICH THE PATIENT HAD REPORTEDLY BEEN TAKING RECENTLY. THE MANUFACTURER WILL FOLLOW UP WITH THE CLINICIAN TO DETERMINE THE CURRENT STATUS OF THE PATIENT.

    Description of Event or Problem · 1

    THE CLINICIAN STATES, THAT THE PATIENT HAD THE IMPLANT PLACED IN SITE #8 IN 2006. THE CLINICIAN REPORTS, THAT THE PATIENT HAD 8-9MM POCKETS BETWEEN SITES #8 & #9. THE PATIENT RETURNED FIFTEEN DAYS LATER FOR SUTURE REMOVAL, NOTHING NOTED. THE PATIENT RETURNED FOR A FOLLOW UP , NOTHING NOTED. SEVENTEEN DAYS LATER, THE CLINICIAN RECEIVED A NOTE FROM THE PATIENT THAT DURING ROUTINE LAB WORK WITH HER PRIMARY CARE PHYSICIAN, SHE WAS FOUND TO HAVE LOW PLATELET COUNT. A SECONDARY LAB WORK WAS RUN TO CONFIRM THE FINDINGS AND SHE WAS PLACED ON PREDNISONE FOR THROMBOCYTOPENIA. SHE WAS ADVISED THAT A SIDE EFFECT OF ONE MEDICATION THAT SHE TOOK (DOXYCYCLINE) CAN CAUSE THROMBOCYTOPENIA, AND WAS WONDERING IF THERE WERE ANY EXPERIENCES LIKE THIS IN THE PAST WITH THE CLINICIAN. THE PATIENT INDICATES SHE IS RESPONDING WELL TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMDOGAIN 0.3 ML MULTI, USA ENAMEL DERIVATIVE NQA BIORA AB NA 1018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention