BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDURA

    MDR report key: 713368 · Received May 12, 2006

    Report

    Report Number
    6000030-2006-00781
    Event Type
    Other
    Date Received
    May 12, 2006
    Report Date
    May 8, 2006
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURERS REPRESENTATIVE REPORTED THE PATIENT HAS DEVELOPED A CYST IN HIS FLANK OVER THE CATHETER SITE AND THE CATHETER HAS DISLODGED. THE INFECTION HAS TRACKED ALONG THE CATHETER WITH REDNESS OVER A SMALL PORTION OF THE CATHETER PATH. THE HCP PLANS TO REVISE THE CATHETER. A FOLLOW UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER LKK RICE CREEK MANUFACTURING 8709AA J12524R18

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention EXPLANTED: UNK.| IMPLANTABLE INFUSION PUMP: MODEL 863740,| LOT# NGV011736N, IMPLANTED: 2005