BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 165756 · Received April 16, 1998

    Report

    Report Number
    3014398-1998-00117
    Event Type
    Injury
    Date Received
    April 16, 1998
    Report Date
    March 18, 1998
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A STENT PROCEDURE, AN ANGIO-SEAL DEVICE WAS UTILIZED FOR HEMOSTASIS IN A PT. THE PT RETURNED TWO DAYS LATER WITH AN INFECTION WHICH AFFECTED BOTH THE PUNCTURE SITE AND THE SURROUNDING SUBCUTANEOUS TISSUE. THE PT WAS PLACED ON ANTIBIOTIC THERAPY (MEDICATIONS UNKNOWN). AS OF 2/13/1998 THE INFECTION IS REPORTED TO HAVE RESOLVED. AS OF 4/13/1998 THERE HAS BEEN NO FURTHER REPORT OF COMPLICATION OR PT SEQUELAE MADE TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB QUINTON INSTRUMENT CO. NA 800668

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention