BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA CATHETER

    MDR report key: 1032921 · Received April 23, 2008

    Report

    Report Number
    6000030-2008-02132
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    December 7, 2007
    Report Date
    December 17, 2007
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT EXPERIENCED WITHDRAWAL SYMPTOMS (UNSPECIFIED). THE HCP ATTEMPTED A CAP STUDY. THE PT'S CATHETER WAS REPLACED DUE TO A POSSIBLE OCCLUSION, AND THE HCP NOTED BLACK SPECKS IN THE END OF THE CATHETER. THE DRUG CONTAINED IN THE PT'S PUMP WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER LKK RICE CREEK MANUFACTURING 8709 J10869R66

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 8627-18| LOT#NGF023457R| PROGRAMMER MODEL PROGRAMMER LOT#UNK| EXPLANTED: