BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 215641 · Received March 24, 1999

    Report

    Report Number
    3032312-1999-00074
    Event Type
    Injury
    Date Received
    March 24, 1999
    Date of Event
    February 23, 1999
    Report Date
    February 26, 1999
    Manufacturer
    THE KENDALL CO.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 02/23/1999 FOLLOWING A DIAGNOSTIC PROCEDURE AN ANGIO-SEAL DEVICE WAS PLACED IN A PATIENT'S GROIN. THE DEPLOYMENT WAS WITHOUT DIFFICULTY AND HEMOSTASIS WAS ACHIEVED. TWO HOURS AFTER THE INSERTION THE PATIENT SPIKED A TEMPERATURE OF 104 DEGREES. URINE, BLOOD AND SPUTUM SAMPLES WERE OBTAINED AND CULTURED WITH NEGATIVE RESULTS. ON 02/27/1999 THE PATIENT WAS STILL BEING TREATED FOR AN INFECTION WITH VANCOMYCIN TWICE DAILY AND GENTAMICIN DAILY (DOSAGE UNKNOWN), WITH THE PATIENT'S HIGHEST TEMPERATURE CHARTED AS 100.6 DEGRRES FOR THIS DAY. AS 0F 03/23/1999 THERE HAS BEEN NO FURTHER REPORT TO THE MANUFACTURER OF COMPLICATION OR ADDITIONAL PATIENT 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 801927

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R