BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 116163 · Received August 28, 1997

    Report

    Report Number
    3014398-1997-00097
    Event Type
    Injury
    Date Received
    August 28, 1997
    Date of Event
    July 11, 1997
    Report Date
    July 30, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 07/11/1997 FOLLOWING A DIAGNOSTIC PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED. COLLAGEN WAS EXPOSED ABOVE THE SKIN LEVEL, AND THERE WAS DIFFICULTY COMPRESSING COLLAGEN POST DEPLOYMENT. THE PATIENT REMAINED IN A SUPINE POSITION FOR 6 HOURS, WHICH IS IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE PATIENT WAS AMBULATED 30 MINUTES PRIOR TO HIS DISCHARGE. LATER THAT EVENING WHILE AT HOME, THE PATIENT FELT A "POP" IN HIS GROIN; A LUMP AND BRUISE DEVELOPED, YET THE PATIENT DID NOT REPORT THIS EXPERIENCE TO HIS PHYSICIAN. FOUR DAYS LATER WHEN THE PATIENT PRESENTED TO HIS PHYSICAN, A LARGE PSEUDONANEURYSM WAS DIAGNOSED WHICH REQUIRED SURGICAL REPAIR. THIS SURGERY OCCURRED ON 07/18/1997.

    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 60 YR Required Intervention