BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE SHOT EPIDURAL TRAY

    MDR report key: 75945 · Received March 14, 1997

    Report

    Report Number
    1217052-1997-00016
    Event Type
    Injury
    Date Received
    March 14, 1997
    Date of Event
    December 31, 1996
    Report Date
    February 14, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    CAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    F.7. THIS REPORT IS A FOLLOW-UP OF THE REPORT SUBMITTED BY SIMS, INC. (THE DEVICE MFR) ON 3/14/97. THE USER FACILITY DID NOT SUBMIT A MEDWATCH REPORT FOR THIS EVENT. F.10. DEVICE CODE #2203 (OTHER): NO DEVICE FAILURE: SIMS HAS NOT RECEIVED ANY SIMILAR REPORTS OF INFECTION AFTER USE OF THIS TRAY FROM ANY OTHER SOURCE. SIMS HAS CONCLUDED THAT THERE IS NO INDICATION THA THE USE OF THIS DEVICE WAS THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    THE HOSP ALLEGES THAT A PT DEVELOPED A STAFF AUREUS INFECTION FOLLOWING AN EPIDURAL THAT NEEDED TO BE SURGICALLY DRAINED. THE CLINICIAN STATES THAT THE INFECTION COULD HAVE COME FROM ANY SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE SHOT EPIDURAL TRAY KIT, CONDUCTION ANESTHETIC CAZ SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA 610528

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention