BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALONEY ESPOHAGEAL BOUGIE

    MDR report key: 257979 · Received January 5, 2000

    Report

    Report Number
    2429473-1999-00099
    Event Type
    Malfunction
    Date Received
    January 5, 2000
    Date of Event
    December 17, 1999
    Report Date
    December 21, 1999
    Manufacturer
    RUSCH, INC.
    Product Code
    KCD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TIP OF THE BOUGIE BROKE OFF DURING USE. DISTAL END WAS NOT RETREIVED AT THE TIME OF THE EVENT. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT MERCURY WAS LEAKING FROM THE BROKEN END OF THE TUBE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TIP OF THE BOUGIE BROKE OFF DURING USE. DISTAL END WAS NOT RETREIVED AT THE TIME OF THE EVENT. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT MERCURY WAS LEAKING FROM THE BROKEN END OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALONEY ESPOHAGEAL BOUGIE ESOPHAGEAL BOUGIE KCD RUSCH, INC. NA 53694

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN