BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL TRAY

    MDR report key: 2771289 · Received October 3, 2012

    Report

    Report Number
    2433012-2012-00001
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    July 30, 2012
    Report Date
    September 24, 2012
    Manufacturer
    BUSSE HOSPITAL DISPOSABLES
    Product Code
    OGE
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EMAIL WAS RECEIVED FROM SALES REPRESENTATIVE OF THE FACILITY, (B)(6). (B)(6) DISPOSABLES HAS REQUESTED MORE INFORMATION AND/OR SAMPLE OF THE PRODUCT TO CONDUCT FURTHER INVESTIGATIONS AND TESTING, AS WELL AS COMPLETION OF THIS FORM ACCURATELY. THE INITIAL REVIEW OF THIS TRAY CONFIRMED THAT THIS KIT HAS THE ACCESSORIES FOR AN EPIDURAL PROCEDURE, WITHOUT INCLUDING THE SPINAL NEEDLE. LOT #: 1230407, MANUFACTURE DATE: 06/20/2012.

    Description of Event or Problem · 1

    THE 3 PATIENTS WERE HOSPITALIZED WITH MENINGITIS. PATIENT NUMBER 1 INJECTED ON (B)(6) 2012. PATIENT NUMBER 2 INJECTED ON (B)(6) 2012. PATIENT NUMBER 3 INJECTED ON (B)(6) 2012. ALL PATIENTS HAVE THOROUGH HISTORY TAKEN, UPON ARRIVAL BP, TEMP ARE TAKEN. NO PATIENT IS INJECTED IF ASSESSMENT IS NOT WITHIN NORMAL RANGES AND A POST ASSESSMENT IS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL TRAY ANESTHESIA CONDUCTION TRAY OGE BUSSE HOSPITAL DISPOSABLES NA 1230625

    Patients

    Seq Age Sex Outcome Treatment
    1