BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVENT

    MDR report key: 2448174 · Received February 13, 2012

    Report

    Report Number
    2448174
    Event Type
    Injury
    Date Received
    February 13, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 18, 2012
    Manufacturer
    EDWARDS L/S
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TIP OF PA - VENT CATHETER REMAINED IN PATIENT'S PULMONARY ARTERY. TIP BROKE OFF AND WAS NOT DISCOVERED AT TIME OF REMOVAL ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVENT PULMONARY CATHETER KIT DYG EDWARDS L/S EV

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention