BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX SPINAL ANESTHESIA TRAYS

    MDR report key: 1871225 · Received October 11, 2010

    Report

    Report Number
    2183502-2010-00443
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 8, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: CUSTOMER HAS NOT YET BEEN RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVAL. 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 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
    1 PORTEX SPINAL ANESTHESIA TRAYS CAZ - ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL ASD, INC. NA 1668276

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention