BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V MUELLER MAXI LOOPS

    MDR report key: 3121800 · Received May 14, 2013

    Report

    Report Number
    MW5030208
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 14, 2013
    Manufacturer
    CARE FUSION
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CAROTID ENDARTERECTOMY, A VESSEL LOOP BROKE SPRAYING BLOOD OVER THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212945 V MUELLER MAXI LOOPS VESSEL LOOP DXC CARE FUSION 101111-2205

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR