BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1103243 · Received May 28, 2008

    Report

    Report Number
    9617604-2008-00067
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL WAS NOTIFIED OF THIS EVENT ON APRIL 16, 2008. HOWEVER, SMITHS MEDICAL ASD WERE NOT NOTIFIED OF THIS EVENT UNTIL MAY 27, 2008. EVAL: SMITHS MEDICAL IS ANTICIPATING THE RETURN ON THE SAMPLE INVOLVED IN THIS EVENT. UPON RETURN OF THE SAMPLE, AND RECEIPT OF THE COMPLETED INVESTIGATION, A F/U REPORT WILL BE SUBMITTED. WE CAN REPORT THAT WE HAVE NOT REC'D ANY OTHER REPORTS ON THIS DEVICE LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. * *

    Patients

    Seq Age Sex Outcome Treatment
    1