BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUTRILINE

    MDR report key: 9202200 · Received October 17, 2019

    Report

    Report Number
    2245270-2019-00067
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    April 30, 2019
    Report Date
    October 11, 2019
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K051690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE NEITHER GOT FURTHER INFORMATION NOR THE SAMPLE FOR ANALYSIS. OUR CEI DOES NOT HAVE INFORMATION OF PERIOD OF USE OR MEDICATION DETAILS. OCCURRENCE RECEIVED FROM ANVISA WHICH PRESERVED THE IDENTITY OF THE CLIENT. CEI RECEIVED THIS NOTIFICATION FROM ANVISA WITH FEW DETAILS ABOUT THE OCCURRENCE. (COMMUNICATION DATE (B)(6) 2019, FIRST GET AWARE DATE FOR VYGON WAS 13.09.2019).

    Description of Event or Problem · 1

    THERE WAS A KNOT IN THE CATHETER WHICH MADE IT IMPOSSIBLE TO REMOVE IT. A VASCULAR SURGEON HAS TO REMOVE THE CATHETER. NO PATIENT INJURY REPORTED, NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998515 NUTRILINE LONG-TERM INTRAVASCULAR, CATHETER LJS VYGON GMBH 1252.35 150118GM

    Patients

    Seq Age Sex Outcome Treatment
    1