BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 4120702 · Received August 21, 2014

    Report

    Report Number
    4120702
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 7, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF VASOVIEW DEVICE FROM RIGHT LEG, A PORTION WAS NOTED TO BE MISSING FROM THE TIP. THE MISSING PIECE WAS RETRIEVED FROM WITHIN THE WOUNDDEVICE WAS GIVEN TO OR SUPPLY CHAIN MANAGER TO RETURN TO THE COMPANY FOR EVALUATION IF INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506122 VASOVIEW HEMOPRO VASCULAR CLOSURE GEI MAQUET CARDIOVASCULAR LLC REF VH-3000 25097345

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR