BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 107351 · Received July 22, 1997

    Report

    Report Number
    3014398-1997-00052
    Event Type
    Malfunction
    Date Received
    July 22, 1997
    Date of Event
    June 20, 1997
    Report Date
    June 23, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A DIAGNOSTIC PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED, AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. HOWEVER, AS THE PT WAS AMBULATING ONE HOUR LATER, THE FORMATION OF A HEMATOMA AND HEAVY BLEEDING WAS NOTED. THE PT WAS GIVEN ONE LITER OF FLUID. DIGITAL PRESSURE WAS ALSO HELD (FOR A DURATION OF ONE HOUR), AND HEMOSTASIS WAS ACHIEVED. THE PT WAS DISCHARGED HOME 24 HOURS LATER IN GOOD CONDITION.

    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 NO INFO Required Intervention