BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX SPINAL ANESTHESIA TRAYS

    MDR report key: 2926250 · Received January 16, 2013

    Report

    Report Number
    2183502-2012-00669
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 15, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    PMA / PMN Number
    PREAMENDEMEN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THAT PT RECEIVED INSUFFICIENT LOCAL ANESTHESIA WHEN THE SUSPECT MEDICAL DEVICE WAS USED. IT WAS NECESSARY TO PLACE THE PT UNDER MONITORED ANESTHESIA CARE (MAC) DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24085 PORTEX SPINAL ANESTHESIA TRAYS CAZ - ANAESTHESIA KIT, SPINAL CAZ SMITHS MEDICAL ASD, INC. NA 2323308

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention