BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH MALONEY ESOPHAGEAL BOUGIE

    MDR report key: 2354051 · Received November 1, 2011

    Report

    Report Number
    3004365956-2011-00449
    Event Type
    Malfunction
    Date Received
    November 1, 2011
    Date of Event
    September 27, 2011
    Report Date
    October 18, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MFR TO EVALUATE. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE SURGEON ACCIDENTALLY PIERCED THE BOUGIE WHILE SUTURING. WHEN THE BOUGIE WAS REMOVED IT WAS LEAKING SMALL AMOUNTS OF TUNGSTEN. THE PT WAS TESTED FOR HEAVY METAL POISONING, WHICH RESULTED IN THE FINDINGS BEING NORMAL. PT CURRENT CONDITION IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1