BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEAL;

    MDR report key: 116332 · Received August 28, 1997

    Report

    Report Number
    3014398-1997-00096
    Event Type
    Malfunction
    Date Received
    August 28, 1997
    Date of Event
    June 25, 1997
    Report Date
    July 29, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    MGB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A PTCA PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. HOWEVER, WHEN THE PT FIRST STOOD UP, OOZING WAS NOTED (LENGTH OF TIME TO AMBULATION UNKNOWN). THE NEXT DAY, THE PT FOUND A HEMATOMA ON HIS LEG. MANUAL PRESSURE AND A FEMOSTOP (PLACED FOR A DURATION OF 12 HRS) WERE USED TO ACHIEVE HEMOSTASIS. FOLLOW-UP THE NEXT DAY CONFIRMED THAT THE PT REMAINED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL; HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB SHERWOOD MEDICAL INDUSTRIES NA 97C081E

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO