BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 118642 · Received September 8, 1997

    Report

    Report Number
    3014398-1997-00103
    Event Type
    Malfunction
    Date Received
    September 8, 1997
    Date of Event
    August 1, 1997
    Report Date
    August 5, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    MGB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A THERAPEUTIC PROCEDURE (PT VENTILATED SUFFERING SUBARACHNOID HEMORRHAGE WHICH WAS TREATED BY A COIL), AN ANGIO-SEAL DEVICE WAS DEPLOYED AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. HOWEVER, SEVERAL HRS LATER BLEEDING WAS NOTED FROM THE PT'S GROIN. THE PT LOST APPROX 2 UNITS OF BLOOD; MANUAL PRESSURE WAS HELD AND HEMOSTASIS WAS AGAIN ACHIEVED. THREE DAYS FOLLOWING THIS EVENT THE PT, WHO WAS VERY ILL, EXPIRED. THE DEATH OF THE PT WAS RELATED TO THE PT'S UNDERLYING MED CONDITION AND UNRELATED TO THE PLACEMENT OF THE ANGIO-SEAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB SHERWOOD MEDICAL INDUSTRIES NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR