BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 77250 · Received March 14, 1997

    Report

    Report Number
    77250
    Event Type
    Injury
    Date Received
    March 14, 1997
    Date of Event
    January 18, 1997
    Report Date
    March 13, 1997
    Manufacturer
    BARD VASCULAR ACCESS
    Product Code
    FOS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ACUTE EPISODE OF ABDOMINAL DISTENTION WITH DESATURATION AND PROGRESSED TO AGONAL RESPIRATIONS. INTUBATED AND MADE NPO, SURGERY CONSULTED. KUB DONE INITIALLY AND THEN ULTRASOUND PERFORMED. ULTRASOUND REVEALED AN INTRA-PARENCHYMAL LESION IN THE RIGHT HEPATIC LOBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD DUAL LUMEN SILICONE 3.5 FR FOS BARD VASCULAR ACCESS 4273505 S1LG1145

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DAY Hospitalization