BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL

    MDR report key: 116819 · Received August 28, 1997

    Report

    Report Number
    3014398-1997-00098
    Event Type
    Malfunction
    Date Received
    August 28, 1997
    Date of Event
    July 21, 1997
    Report Date
    July 31, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    MGB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A STENT PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED AND HEMOSTASIS WAS ACHIEVED. HOWEVER, UPON REMOVAL OF THE DEVICE TENSION SPRING 20 MINUTES LATER (IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE), SLIGHT OOZING WAS NOTED. MANUAL PRESSURE WAS HELD AND HEMOSTASIS WAS ACHIEVED. DURING THE NIGHT, THE PT EXPERIENCED PAIN IN HIS LEG. AT THE TIME HE NOTED BLOOD SOAKED SHEETS. MANUAL PRESSURE WAS HELD, AND HEMOSTASIS WAS AGAIN ACHIEVED. AS OF 07/31/1997, THE PT IS DOING WELL; HOWEVER, HE EXPERIENCED SEVERE BRUISING TO THE KNEE. IT IS IMPORTANT TO NOTE THAT THIS PT HAD HIS DIAGNOSTIC PROCEDURE APPROXIMATELY SEVEN WEEKS PRIOR USING THE SAME PUNCTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HENOSTATIC PUNCTURE CLOSURE DEVICE MGB SHERWOOD MEDICAL INDUSTRIES NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO