BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PER CLOSE CLOSURE DEVICE

    MDR report key: 2892861 · Received December 21, 2012

    Report

    Report Number
    MW5028393
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 12, 2012
    Manufacturer
    ABBOTT LAB
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CLOSURE DEVICE DEPLOYED POST CATH TO RIGHT GROIN. CLOSURE DEVICE FAILED CAUSING INJURY TO RIGHT FEMORAL ARTERY. PT SENT TO SURGERY FOR ARTERY REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PER CLOSE CLOSURE DEVICE NONE MGB ABBOTT LAB 1267 20802J1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention