BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHURCHILL INFUSION SET WITH DISC

    MDR report key: 53779 · Received July 1, 1996

    Report

    Report Number
    53779
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    May 11, 1996
    Report Date
    May 20, 1996
    Manufacturer
    CHURCHILL MEDICAL SYSTEMS, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS NOTED TO HAVE ADRIAMYCIN UNDER BIOOCCLUSIVE DRESSING. DID NOT APPEAR TO BE INFILTRATING THE PAC POCKET, BUT APPEARED TO BE FROM EXTERNAL TUBING CONNECTION. SOME SLOUGHING OF SKIN OCCURRED WITH UNDERLYING TISSUE EXPOSURE TO CHEMO. SITE WASHED AND ICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHURCHILL INFUSION SET WITH DISC INFUSON SET WITH DISC FOZ CHURCHILL MEDICAL SYSTEMS, INC. * 5K15, 3E36, L4K67, 5E28

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention