BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 8345844 · Received February 15, 2019

    Report

    Report Number
    3010611950-2019-00009
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    January 8, 2019
    Report Date
    January 15, 2019
    Manufacturer
    NATUS NEURO INCORPORATED
    Product Code
    JXG
    UDI-DI
    10886704040910
    PMA / PMN Number
    K954021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE (B)(4). PRODUCT RETURN FOLLOW UP MADE 14-JAN-2019, 21-JAN-2019 AND 28-JAN-2019.

    Description of Event or Problem · 1

    STOPCOCK DISCONNECTED FROM TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136230 CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NATUS NEURO INCORPORATED 821731 10886704040910

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other