BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE

    MDR report key: 242047 · Received September 27, 1999

    Report

    Report Number
    2182269-1999-00023
    Event Type
    Injury
    Date Received
    September 27, 1999
    Date of Event
    October 2, 1998
    Report Date
    September 24, 1999
    Manufacturer
    DAIG CORP.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANGIO-SEAL DEVICE WAS DEPLOYED WITHOUT DIFFICULTY ON 10/02/1998 FOLLOWING A DIAGNOSTIC PROCEDURE. THE PT RETURNED ON 11/02/1998 WHEN A PLASMA THROMBOPLASTIN ACTECEDENT (PTA) OF THE COMMON FEMORAL ARTERY WAS PERFORMED. THE PT'S CONDITION WAS NOTED TO BE IMPROVED. NO FURTHER INFORMATION HAS BEEN REPORTED TO THE MFR.

    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. 610089 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention