BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROPHOCAN CVS CATHETER

    MDR report key: 63261 · Received January 3, 1997

    Report

    Report Number
    1217052-1997-00001
    Event Type
    Injury
    Date Received
    January 3, 1997
    Date of Event
    May 28, 1996
    Report Date
    December 2, 1996
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    LLX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A.4, D.6. UNK - FOLLOW-UP WITH THE HOSPITAL REVEALS THAT THIS INFO IS UNK BECAUSE IT WAS NOT RECORDED ON THE PATIENT'S CHART. NOTE: NO ADDITIONAL INFO IS AVAILABLE FOR SECTION F BECAUSE THIS EVENT WAS NOT REPORTED BY THE INITIAL REPORTER TO THE USER FACILITIES MDR CONTACT PERSON.

    Description of Event or Problem · 1

    DURING THE CVS PROCEDURE, A LEFT OVARIAN CORPUS LUTEAL CYST WAS SEEN MEASURING 3.1 X 3.3 X 2.4 CMA. NO ADNEXAL MASSES OR FREE FLUID WERE VISUALIZED. THE AMNIOTIC FLUID VOLUME APPEARED NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROPHOCAN CVS CATHETER CATHETER, SAMPLING, CHORIONIC VILLUS LLX SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention SYRINGE