BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALONEY TUNGSTEN FILLED BOUGIE 34F

    MDR report key: 3868431 · Received May 5, 2014

    Report

    Report Number
    3004365956-2014-00191
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    TELEFLEX
    Product Code
    KCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ROLLED ITSELF INTO THE STOMACH AND WHEN THE SURGEON TRIED TO REMOVE IT, THE TIP WAS BLOCKED INSIDE THE STAPLES AND THE TIP OF THE DEVICE BROKE OFF. THE TIP AND THE REST OF THE BOUGIE WAS RECOVERED. ANOTHER BOUGIE WAS USED. NO OTHER ISSUE. THE PATIENT IS FINE. NO CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267840 MALONEY TUNGSTEN FILLED BOUGIE 34F KCD TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1