BEUDAMED
    FDA Adverse Event Other Summary report: N

    JIMMY JOHN III

    MDR report key: 493975 · Received October 28, 2003

    Report

    Report Number
    1640200-2003-00003
    Event Type
    Other
    Date Received
    October 28, 2003
    Date of Event
    December 13, 2001
    Report Date
    October 28, 2003
    Manufacturer
    COLON THERAPEUTICS INC.
    Product Code
    KPL
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    CLAIM OF AN UNSPECIFIED ALLEGED COLON PERFORATION THE END USER CLAIMS TO HAVE RECEIVED AT AN USER FACILITY. MANUFACTURER INVESTIGATION INTO THE ALLEGED CLAIM, DISCOVERED DEVICE DID NOT MALFUNCTION, IS STILL OPERATIONAL AND CONTINUES TO OPERATE AS INTENDED AND DESIGNED, WITH NO FURTHER REPORT OF INCIDENCE. DEVICE IN QUESTION WAS NOT RETURNED TO MANUFACTURER. MANUFACTURER HAS REQUESTED MORE INFORMATION INTO THE ALLEGED PERFORATION AND EVIDENCE INTO THE ALLEGED PERFORATION BEING CAUSED BY THE COLONIC DEVICE, BUT TO DATE NONE HAS BEEN PROVIDED SUCH AS TYPE OF COLON SCOPE USED, ACTUAL MEDICAL HISTORY OF THE USER, MEDICAL REPORTS OF ALLEGED PERFORATION AND CAUSE, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JIMMY JOHN III COLONIC ENEMA DEVICE KPL COLON THERAPEUTICS INC. 2-C *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O