BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR

    MDR report key: 746623 · Received September 29, 2005

    Report

    Report Number
    MW1036739
    Event Type
    Malfunction
    Date Received
    September 29, 2005
    Date of Event
    September 22, 2005
    Report Date
    September 22, 2005
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE DID NOT WORK CORRECTLY. IT WAS HARD TO REMOVE FROM PT. REQUEST EVALUATION OF DEVICE FROM PHYSICIAN. NO PATIENT INJURY. HAD TO HOLD PRESSURE MANNUALLY TO ACHIEVE HEMOSTASIS OF THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR PERCLOSE PRODGLIDE MGB ABBOTT VASCULAR * 39922-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR