BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 2973742 · Received July 20, 2007

    Report

    Report Number
    6000030-2006-02452
    Event Type
    Injury
    Date Received
    July 20, 2007
    Report Date
    July 22, 2004
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTS HE "FELL OVER BACKWARDS" ONE MONTH AGO AND FOR THE LAST TWO WEEKS IS EXPERIENCING BURNING NUMBING PAIN IN HIS ABDOMINAL, BACK, LEGS AND FEET AREA. A CATHETER STUDY REVEALED A SPOT ON THE CATHETER AN MRI REVEALED A GRANULOMA. THE PT REPORTS HE HAS A RARE TUMOR THAT WAS DISCOVERED IN (B)(6) 2001 NEAR THE SPOT WHERE THE GRANULOMA IS LOCATED. THE MANUFACTURER REQUESTED ADDITIONAL INFO AND CONFIRMATION OF THIS EVENT, HOWEVER, NO INFO WAS RECEIVED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709AA J11343R16

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTABLE INFUSION PUMP: MODEL 8627L18,| IMPLANTED:| LOT# NGH027434R