BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART-CHILL CARDIAC & PHRENIC INSULATOR

    MDR report key: 3084811 · Received April 23, 2013

    Report

    Report Number
    MW5029941
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 23, 2013
    Manufacturer
    GENESEE BIOMEDICAL, INC.
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CARDIOVASCULAR PROCEDURE A PHRENIC INSULATOR PAD WAS USED. THE PAD INCLUDES A RADIOPAQUE STRIP. THE PATIENT RECEIVED AN X-RAY AND THE PAD WAS NOT NOTED BY EITHER THE PHYSICIAN ASSISTANT OR THE RADIOLOGIST, AS THE STRIP DID NOT APPEAR IN THE X-RAY. A FOREIGN BODY WAS RETAINED. REASON FOR USE: CORONARY ARTERY BYPASS GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173543 HEART-CHILL CARDIAC & PHRENIC INSULATOR PHRENIC PAD DWC GENESEE BIOMEDICAL, INC. CI12110

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other