BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSEAL

    MDR report key: 2042998 · Received March 29, 2011

    Report

    Report Number
    2042998
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ST. JUDE
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TAMP-TUBE OF DEVICE DID NOT SLIDE DOWN AS IT SHOULD. OPERATOR HAD TO MANUALLY PULL DOWN TAMP-TUBE TO MAKE DEVICE WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSEAL DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE * 3262508
    2 ANGIOSEAL DEVICE, HEMOSTASIS, VASCULAR MGB S.T JUDE * 3262508

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES
    2