BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE

    MDR report key: 249764 · Received November 16, 1999

    Report

    Report Number
    2182269-1999-00064
    Event Type
    Injury
    Date Received
    November 16, 1999
    Date of Event
    October 13, 1999
    Report Date
    November 15, 1999
    Manufacturer
    DAIG CORP.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANGIO-SEAL DEVICE WAS DEPLOYED ON OCTOBER 13, 1999. SUBSEQUENT INTERNAL BLEEDING WAS NOTED WHICH REQUIRED SURGICAL INTERVENTION AND REPAIR. THE ANGIO-SEAL DEVICE WAS EXPLANTED IN 1999. PT IS REPORTEDLY IN SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE Implant 8F ANGIO-SEAL MGB DAIG CORP. 610090 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention