BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX SPINAL ANESTHESIA TRAYS

    MDR report key: 4102606 · Received September 12, 2014

    Report

    Report Number
    2183502-2014-00671
    Event Type
    Injury
    Date Received
    September 12, 2014
    Report Date
    September 11, 2014
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K965017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED ENTIRE FORM. ADDITIONAL MANUFACTURER NARRATIVE: CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT STATED A PATIENT RECEIVED INSUFFICIENT LOCAL ANESTHESIA WHEN THE LISTED MEDICAL DEVICE WAS USED. IT WAS NECESSARY TO PLACE PATIENT UNDER GENERAL ANESTHESIA DURING THE PROCEDURE. NO ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565003 PORTEX SPINAL ANESTHESIA TRAYS CAZ, ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL ASD, INC. NA 2737475

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention