BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UMI

    MDR report key: 121159 · Received September 15, 1997

    Report

    Report Number
    121159
    Event Type
    Injury
    Date Received
    September 15, 1997
    Date of Event
    June 5, 1997
    Report Date
    August 7, 1997
    Manufacturer
    UNIVERSAL MEDICAL INSTRUMENT CORP.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CARDIAC CATHETERIZATION PERFORMED. PT'S CONDITION WAS STABLE FOLLOWING THE PROCEDURE. REVIEW OF A CXR SHOWED A RETAINED CATHETER. THE RETAINED CATHETER WAS SUCCESSFULLY REMOVED IN THE CARDIAC CATH LAB. THE PT HAD NO LONG TERM SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMI 3-50 PIGTAIL CATHETER DQO UNIVERSAL MEDICAL INSTRUMENT CORP. 1310-21-0053 *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention