BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIO-SEAL

    MDR report key: 147746 · Received February 6, 1998

    Report

    Report Number
    3014398-1998-00021
    Event Type
    Other
    Date Received
    February 6, 1998
    Date of Event
    December 9, 1997
    Report Date
    December 10, 1997
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 12/05/1997 A PT UNDERWENT BOTH A DIAGNOSTIC CATHETERIZATION AND PTCA PROCEDURE WITH AN ANGIO-SEAL PLACEMENT IN THE RIGHT GROIN. ON 12/08/1997 THE SAME PT UNDERWENT A PTCA WITH ANGIO-SEAL PLACEMENT TO THE LEFT GROIN. ON 12/09/1997 THE PT WAS DISCHARGED HOME. ON THE EVENING OF 12/09/1997 FOLLOWING HIS DISCHARGE FROM THE HOSP, THE PT NOTED BLOOD SATURATION OF HIS INITIAL DRESSING IN HIS LEFT GROIN. HE PRESENTED TO THE ER WHERE THE SITE WAS REBANDAGED AND HE WAS SENT HOME. ON 12/10/1997 THE PT SAW HIS CARDIOLOGIST, WHO REHOSPITALIZED THE PT AND ADMINISTERED BOTH A SANDBAG AND PRESSURE BANDAGE WHICH RESULTED IN RESOLUTION OF THE OOZING. HOWEVER, THE PT REMAINED HOSPITALIZED UNTIL 12/13/1997 (PT BELIEVES THE HOSP STAFF WAS BEING CAUTIOUS DUE TO HIS BEING A HOSP ADMINISTRATOR). FOLLOW-UP SIX DAYS LATER CONFIRMED THAT BOTH GROINS WERE COMPLETELY HEALED AND THE PT REMAINED WITHOUT FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB QUINTON INSTRUMENT CO. NA 801373 OR 801376

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization