BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELEFLEX MEDICAL

    MDR report key: 998081 · Received February 11, 2008

    Report

    Report Number
    MW5005429
    Event Type
    Injury
    Date Received
    February 11, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 11, 2008
    Manufacturer
    TELEFLEX
    Product Code
    KNQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN ESOPHAGEAL DILATION WAS BEING PERFORMED AND A 30F JACKSON DILATOR CAME APART DURING THE PROCEDURE. IT REQUIRED AN EGD FOR RETRIEVAL. DIAGNOSIS: ESOPHAGEAL STRICTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEFLEX MEDICAL 30FR JACKSON DILATOR KNQ TELEFLEX 507830

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability