BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX SPINAL ANESTHESIA TRAYS

    MDR report key: 4102604 · Received September 12, 2014

    Report

    Report Number
    2183502-2014-00673
    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 A PATIENT UNDER GENERAL ANESTHESIA DURING THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565166 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