BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSIGRAFT (EPTOTERMIN ALFA)

    MDR report key: 1981220 · Received January 31, 2011

    Report

    Report Number
    1224732-2011-00001
    Event Type
    Other
    Date Received
    January 31, 2011
    Date of Event
    October 22, 2010
    Report Date
    January 11, 2011
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, STRYKER BIOTECH RECEIVED A REPORT THAT A PT (DEMOGRAPHICS UNK) DEVELOPED AN INCREASED MONOCYTE COUNT APPROX FIVE MONTHS AFTER UNDERGOING AN UNSPECIFIED PROCEDURE. NO ADD'L INFO WAS RECEIVED IN THE INITIAL REPORT. F/U INFO RECEIVED ON (B)(6) 2011 CONFIRMED THAT THE PT (B)(6), A (B)(6) FEMALE EXPERIENCED HIGH LEVELS OF MONOCYTES WITH AN ONSET DATE OF (B)(6) 2010. THE REPORTER STATED THAT HE DID NOT KNOW WHETHER THE ADVERSE EVENT WAS RELATED TO THE PRODUCT, BUT STATED THAT THE EVENT WAS NOT LIFE THREATENING, DID NOT REQUIRE HOSPITALIZATION, AND THAT IT DID NOT REQUIRE MEDICAL INTERVENTION. THE REPORTER ALSO STATED THAT HE DID NOT KNOW WHETHER THE PT HAD RECOVERED FROM THE EVENTS. FURTHER INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSIGRAFT (EPTOTERMIN ALFA) IMPLANT MPY STRYKER BIOTECH NA EU10027

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other