BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADROX-ID AD.O.FIL.

    MDR report key: 4606201 · Received March 12, 2015

    Report

    Report Number
    3008355164-2015-00039
    Event Type
    Injury
    Date Received
    March 12, 2015
    Date of Event
    February 12, 2015
    Report Date
    February 13, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS BLOOD LOSS FROM THE GAS OUTLET OF APPROXIMATELY 20 CC. THE REPLACEMENT DEVICE ALSO LEAKED. THIS EVENT IS RELATED TO MEDWATCH REPORT # 8010762-2015-00252 AND 3008355164-2015-00040 FOR THE SECOND DEVICE. (B)(4). REFERENCE MFR # 8010762-2015-00251.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170717 QUADROX-ID AD.O.FIL. BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL. DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD70000-USA 70100705

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention