BEUDAMED
    FDA Adverse Event Summary report: N

    THE PROMETRA CATHETER

    MDR report key: 3193630 · Received June 21, 2013

    Report

    Report Number
    MW5030688
    Date Received
    June 21, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 21, 2013
    Manufacturer
    FLOWONIX MEDICAL
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTRATHECAL CATHETER SHEARED AND DECISION WAS MADE TO LEAVE THE SHEARED PIECE IN AFTER AN INTRAOPERATIVE NEUROSURGERY CONSULT. PROMETRA PROGRAMMABLE PUMP WAS TO BE ATTACHED TO THE INTRATHECAL CATHETER BUT PROCEDURE WAS ABORTED. DIAGNOSIS OR REASON FOR USE: PAIN CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283857 THE PROMETRA CATHETER INTRATHECAL CATHETER LKK FLOWONIX MEDICAL 11823 18641

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization