BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9617604-2008-00098

    MDR report key: 1110895 · Received August 4, 2008

    Report

    Report Number
    9617604-2008-00098
    Event Type
    Injury
    Date Received
    August 4, 2008
    Product Code
    BSY
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS EVAL: SMITHS MEDICAL IS STILL TRYING TO OBTAIN FURTHER INFO FROM THE USER FACILITY. TO DATE, WE CAN REPORT THAT WE HAVE NO OTHER REPORTS ON TWO POSSIBLE LOTS PROVIDED. NO SAMPLES HAVE BEEN RETURNED. NO OTHER FACILITY EXPERIENCING ANY DIFFICULTIES. IF WE ARE ABLE TO OBTAIN FURTER INFO, OR SAMPLES, THEN A F/U REPORT WILL BE SUBMITTED. IF NO FURTHER INFO PROVIDED THEN THIS WILL BE AN UNCONFIRMED REPORT AND UNABLE TO DETERMINE IF RELATED TO DEVICE OR USER INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BSY * *

    Patients

    Seq Age Sex Outcome Treatment
    1