BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 213528 · Received March 4, 1999

    Report

    Report Number
    3032312-1999-00051
    Event Type
    Injury
    Date Received
    March 4, 1999
    Date of Event
    January 29, 1999
    Report Date
    February 1, 1999
    Manufacturer
    THE KENDALL CO.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 02/01/1999 FOLLOWING A DIAGNOSTIC PROCEDURE AN ANGIO-SEAL DEVICE WAS PLACED IN A PT'S RIGHT GROIN. REPORTEDLY THE PHYSICIAN NOTED THAT THE DEPLOYMENT "FELT DIFFERENT." THE PT WAS DISCHARGED APPROX SIX HOURS POST-DEPLOYMENT. ON 01/29/1999 THE PT WAS IN THE BATHROOM WHEN A "GUSH" WAS NOTED AT THE RIGHT GROIN SITE. THE PT WAS ASSISTED TO THE FLOOR BY A FAMILY MEMBER, PRESSURE WAS APPLIED (DURATION UNK) AND BLEEDING WAS CONTROLLED. ON 01/30/1999 THE PT WAS SEEN IN THE RADIOLOGY DEPARTMENT WERE A 1 - 2 CM HEMATOMA WAS NOTED WITH A SMALL BRUISE. AS OF 03/01/1999 THERE HAS BEEN NO FURTHER REPORT TO THE MFR OF COMPLICATION OR ADDITIONAL PT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB THE KENDALL CO. NA 100858

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention