BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECONOKATH

    MDR report key: 2601854 · Received September 20, 2006

    Report

    Report Number
    1316297-2006-00002
    Event Type
    Other
    Date Received
    September 20, 2006
    Date of Event
    August 9, 2006
    Report Date
    September 20, 2006
    Manufacturer
    EPIMED INTERNATIONAL
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR WAS NOTIFIED AND RECOMMENDED THE PHYSICIAN CONTACT A NEUROSURGEON TO DETERMINE WHAT THE NEXT STEP SHOULD BE. AT THE TIME OF THIS REPORT MFR HAS BEEN UNABLE TO CONTACT THE PHYSICIAN TO FIND OUT THE OUTCOME OF THIS EVENT.

    Description of Event or Problem · 1

    PHYSICIAN COMPLETED PROCEDURE USING EPIDURAL NEEDLE AND CATHETER AND UPON REMOVAL OF THE CATHETER RESISTANCE WAS ENCOUNTERED. PHYSICIAN CONTINUED TO REMOVE CATHETER. AFTER REMOVAL IT WAS NOTICED THAT 1/8" TO 1/4" OF THE CATHETER REMAINED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECONOKATH EPIDURAL CATHETER BSO EPIMED INTERNATIONAL 154-1912 11122164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EPIDURAL NEEDLE