BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA CATHETER

    MDR report key: 1002592 · Received February 8, 2008

    Report

    Report Number
    6000030-2008-00634
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    December 1, 2003
    Report Date
    October 16, 2007
    Manufacturer
    RICE CREEK MANUFACTRING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PT'S CATHETER TORE. THE PT'S CATHETER WAS REPLACED. THE DISTAL PORTION REMAINED IMPLANTED AFTER THE CATHETER WAS REPLACED. NO PT SYMPTOMS WERE REPORTED. THE PT RECOVERED WITHOUT SEQUELA. REFERENCE MFR REPORT # 6000030200800632, 6000030200800633.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER LKK RICE CREEK MANUFACTRING 8709 J10994R09

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention LOT # NGF026230R| IMPLANTED| IMPLANTABLE INFUSION PUMP MODEL 8627-18| EXPLANTED| IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK