BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSATION 7 FR 40 CM

    MDR report key: 2182282 · Received July 22, 2011

    Report

    Report Number
    MW5021502
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 22, 2011
    Manufacturer
    MAQUET, DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON PUMP ALARMED. BLOOD NOTED IN TUBING. BALLOON STOPPED AND REMOVED. REASON FOR USE: CORONARY ARTERY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATION 7 FR 40 CM BALLOON PUMP DSP MAQUET, DATASCOPE CORP. 0684-00-0470-01 2551

    Patients

    Seq Age Sex Outcome Treatment
    1