BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT LABORATORIES

    MDR report key: 284016 · Received June 27, 2000

    Report

    Report Number
    MW1019202
    Event Type
    Injury
    Date Received
    June 27, 2000
    Date of Event
    June 17, 2000
    Report Date
    June 27, 2000
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2000 RADIOLOGIST USED A "PERCLOSE" DEVICE IN THE PT'S RIGHT COMMON FEMORAL ARTERY FOLLOWING AN ANGIOGRAPHY. ON 6/12/00 THE PT WAS READMITTED WITH COLD PAINFUL RIGHT FOOT. FIVE DAYS LATER A SURGEON TOOK THE PT TO THE OR TO EXPLORE THE RIGHT COMMON REMORAL ARTERY. DR FOUND THE "PERCLOSE" DEVICE "EMBEDDED IN THE BACK WALL OF THE VESSEL" AND REMOVED IT AS A "FOREIGN BODY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT LABORATORIES "PERCLOSE" DEVICE MGB ABBOTT LABORATORIES, INC. 6 FR. SMC SYSTEM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention