BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA CATHETER

    MDR report key: 1000719 · Received February 15, 2008

    Report

    Report Number
    6000030-2008-00765
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Report Date
    January 27, 2006
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THE PT HAS BEEN EXPERIENCING WITHDRAWAL SYMPTOMS INCLUDING INCREASED PAIN, ABDOMINAL PAIN, AND SHIVERING CHILLS. A DYE STUDY WAS DONE AND THE CATHETER WAS REVISED. THE PT OUTCOME WAS REPORTED AS CONTINUING TO RECOVER IN THE HOSPITAL WITH OTHER HEALTH PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER LKK RICE CREEK MFG 8709 J10813R60

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R