BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLING

    MDR report key: 8277961 · Received January 24, 2019

    Report

    Report Number
    MW5083391
    Event Type
    Injury
    Date Received
    January 24, 2019
    Date of Event
    January 22, 2019
    Report Date
    January 22, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KCD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MFR IDENTIFIED ISSUES WITH THE OUTER PACKAGING OF THE PRODUCTS BEING IMPROPERLY LABELED. THE PRODUCT ITSELF IS PROPERLY LABELED. BECAUSE OF THIS, MANUFACTURER RECOMMENDS REMOVING PRODUCT CONTAINERS OUT OF SERVICE. HOWEVER, OUR FACILITY ALWAYS IMMEDIATELY REMOVES ITEMS FROM THE CONTAINER AND VERIFIES SIZE ON THE DEVICE ITSELF. AND SINCE THE DEVICE ITSELF IS NOT AN ISSUE, AND PACKAGING IS IMMEDIATELY DISCARDED, NO FURTHER ACTION IS NEEDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65859 PILLING BOUGIE, ESOPHAGEAL, ENT KCD TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention