BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8.5 FR NEPHROSTOMY TUBE

    MDR report key: 467484 · Received June 18, 2003

    Report

    Report Number
    467484
    Event Type
    Injury
    Date Received
    June 18, 2003
    Date of Event
    June 17, 2003
    Report Date
    June 17, 2003
    Manufacturer
    COOK INC
    Product Code
    LJE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SIZE 8.5 FR J STENT PLACED FOR LEFT UPJ OBSTRUCTION. PT EXPERIENCED MULTIPLE BREAKS OF NEPHROSTOMY TUBE REQUIRING MULTIPLE REPAIRS. PT EXPERIENCED LEFT FLANK PAIN & INABILITY TO IRRIGATE CATHETER. CATHETER WAS BROKEN AND HAD MIGRATED OUT. REQUIRED EMERGENCY SURGERY TO REPLACE WITH 12.0 FR DRAINAGE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.5 FR NEPHROSTOMY TUBE 8.5 FR NEPHROSTOMY TUBE LJE COOK INC * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| R