BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROPHOCAN CVS CATHETER

    MDR report key: 219064 · Received April 16, 1999

    Report

    Report Number
    1217052-1999-00012
    Event Type
    Injury
    Date Received
    April 16, 1999
    Date of Event
    March 11, 1991
    Report Date
    March 18, 1999
    Manufacturer
    SIMS PORTEX INC.
    Product Code
    LLX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE CHILD OF A MOTHER WHO UNDERWENT THE CVS PROCEDURE ON 3/11/1991 WAS ALLEGEDLY BORN WITH BILATERAL CLUB FEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROPHOCAN CVS CATHETER CATHETER, SAMPLING, CHORIONIC VILLUS LLX SIMS PORTEX INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 * Congenital Anomaly A SYRINGE. (3/11/1991 TO 3/11/1991).