BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALONEY 60FR ESOPHAGEAL BOUGIE

    MDR report key: 137136 · Received December 8, 1997

    Report

    Report Number
    2429473-1997-00116
    Event Type
    Injury
    Date Received
    December 8, 1997
    Date of Event
    December 5, 1997
    Report Date
    December 5, 1997
    Manufacturer
    RUSCH, INC.
    Product Code
    KCD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS STATED THAT THE DEVICE WAS RECEIVED ON NOVEMBER 27,1997 AND USED FOR A PROCEDURE ON NOVEMBER 28,1997. TODAY, AFTER SOAKING THE BOUGIE, IT WAS TO BE PUT AWAY AND A CRACK WAS NOTICED TOWARD THE TIP OF THE BOUGIE. NO HARM TO PT AND NO APPARENT LEAKING OF MERCURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALONEY 60FR ESOPHAGEAL BOUGIE BOUGIE DIALATOR KCD RUSCH, INC. NA 725025

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other