BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (STOCKERT) SORIN GROUP DEUTSCHLAND GMBH

    MDR report key: 621102 · Received July 8, 2005

    Report

    Report Number
    621102
    Event Type
    Injury
    Date Received
    July 8, 2005
    Date of Event
    June 20, 2005
    Report Date
    June 30, 2005
    Manufacturer
    BORIN GROUP
    Product Code
    DWB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING OPEN HEART SURGERY TO CORRECT SUB-AORTIC STENOSIS, PT REPORTEDLY SUFFERED AN AIR EMBOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 (STOCKERT) SORIN GROUP DEUTSCHLAND GMBH CARDIOPULMONARY BYPASS MACHINE DWB BORIN GROUP S3 CONSOLE *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Disability