BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX SPINAL ANESTHESIA TRAYS

    MDR report key: 2945783 · Received February 1, 2013

    Report

    Report Number
    2183502-2013-00002
    Event Type
    Injury
    Date Received
    February 1, 2013
    Report Date
    January 30, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT STATED THAT A PT RECEIVED INSUFFICIENT LOCAL ANESTHESIA WHEN THE SUSPECT MEDICAL DEVICE WAS USED. IT WAS NECESSARY TO PLACE THE PT UNDER GENERAL ANESTHESIA DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44407 PORTEX SPINAL ANESTHESIA TRAYS CAZ - ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL ASD, INC. NA 2372217

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention