BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLANGIOGRAPHY SET

    MDR report key: 11444 · Received February 11, 1994

    Report

    Report Number
    MW1000730
    Event Type
    Malfunction
    Date Received
    February 11, 1994
    Date of Event
    December 20, 1993
    Report Date
    January 24, 1994
    Manufacturer
    AMERICAN CATHETER CORP.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CHOLANGIOGRAPHY SET WAS BROKEN ON THE FIELD BEFORE IT WAS INSERTED. THE DR WANTED IT REMOVED FROM THE FIELD AND WANTED TO USE A DIFFERENT TYPE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLANGIOGRAPHY SET DQO AMERICAN CATHETER CORP. 31192

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other