BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA CATHETER

    MDR report key: 1021060 · Received March 27, 2008

    Report

    Report Number
    6000030-2008-01633
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    February 26, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PATIENT REPORTED, THAT HER DEVICE SYSTEM WAS REMOVED DUE TO MENINGITIS. NO PATIENT SYMPTOMS OR OUTCOME WAS REPORTED. THE DRUG CONTAINED IN THE PATIENT'S PUMP WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER LKK RICE CREEK MANUFACTURING 8709 N086126026

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| IMPLANTABLE INFUSION PUMP MODEL 863740| EXPLANTED| PROGRAMMER MODEL 8840| LOT # NGV401171H