BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX SPINAL ANESTHESIA TRAYS

    MDR report key: 3021105 · Received March 15, 2013

    Report

    Report Number
    2183502-2013-00097
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 12, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    CAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT STATED THAT PT REC'D 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
    110830 PORTEX SPINAL ANESTHESIA TRAYS CAZ - ANAESTHESIA KIT, SPINAL CAZ SMITHS MEDICAL ASD, INC NA 22-633-EV

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention