BEUDAMED
    FDA Adverse Event Summary report: N

    OSIGRAFT

    MDR report key: 2891696 · Received December 18, 2012

    Report

    Report Number
    1224732-2012-00082
    Date Received
    December 18, 2012
    Report Date
    December 1, 2012
    Manufacturer
    OLYMPUS BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2012, OLYMPUS BIOTECH RECEIVED A REPORT OF AN ADVERSE EVENT THROUGH THE QUINTILES CALL CENTER INVOLVING A (B)(6) FEMALE PT WHO WAS ADMINISTERED OSIGRAFT AS PART OF AN UNSPECIFIED BONE LENGTHENING PROCEDURE "WITH ILIZAROV TECHNIQUE." APPROX 15 DAYS POST-PROCEDURALLY, THE PT WAS REPORTED TO HAVE EXPERIENCED REDNESS, PAIN, SWELLING AND A "PULSATING" SENSATION IN HER LEG. THE PT WAS ALSO REPORTED TO BE "CONTINUOUSLY STRETCHING THE LEG." NO ADDITIONAL INFO WAS RECEIVED WITH THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSIGRAFT NONE MPY OLYMPUS BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR NO CONCOMITANT DRUGS AVAILABLE