BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTEX® EPIDURAL MINIPACKS

    MDR report key: 7706311 · Received July 20, 2018

    Report

    Report Number
    3012307300-2018-02892
    Event Type
    Death
    Date Received
    July 20, 2018
    Date of Event
    January 12, 2018
    Report Date
    July 20, 2018
    Manufacturer
    SMITHS MEDICAL ASD; INC.
    Product Code
    CAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING REMOVAL OF A SMITHS MEDICAL PORTEX® EPIDURAL MINIPACK A HEMATOMA FORMED. SUBSEQUENTLY, LOWER EXTREMITY PARALYSIS OCCURRED REQUIRING THAT A LAMINECTOMY BE PERFORMED UNDER GENERAL ANESTHESIA. IT WAS NOTED THAT THE PATIENT WAS HOSPITALIZED FOR LUNG CANCER IN WHICH THE PATIENT UNDERWENT A LOBECTOMY. HOWEVER, THE PATIENT EXPIRED 36 DAYS FOLLOWING DUE TO SEPSIS (GENERAL COMPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549364 PORTEX® EPIDURAL MINIPACKS ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL ASD; INC. 3470048

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L