BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH MALONEY ESOPHAGEAL BOUGIE

    MDR report key: 1166064 · Received September 18, 2008

    Report

    Report Number
    3004365956-2008-00046
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Report Date
    July 7, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE AVAILABLE FOR EVALUATION. INVESTIGATION IS ONGOING AND AN INVESTIGATION REPORT WILL FOLLOW WHEN FINISHED.

    Description of Event or Problem · 1

    INCIDENT REPORTED AS: HOSPITAL REPORTED THAT THE PRODUCT LEAKED A "SLIGHT" AMOUNT OF TUNGSTEN INTO THE PATIENT. THE PATIENT IS FINE. THE PATIENT'S ESOPHAGUS AND MOUTH WERE FLUSHED AND NO PATIENT INJURY WAS NOTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH MALONEY ESOPHAGEAL BOUGIE ESOPHAGEAL BOUGIE KCD TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1