BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMCON PATCH

    MDR report key: 1711563 · Received June 3, 2010

    Report

    Report Number
    MW5016192
    Event Type
    Malfunction
    Date Received
    June 3, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 24, 2010
    Manufacturer
    HEMCON MEDICAL TECHNOLOGIES, INC.
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT S/P CORONARY ANGIOPLASTY AND STENT PLACEMENT ON (B) (6) 2010. POST REMOVAL OF THE INTRODUCER (RIGHT GROIN): MANUAL PRESSURE FOR 20 MINUTES APPLIED, FOLLOWED BY HEMCON PATCH AND TEGADERM TO SITE. APPROX 45 MINUTES LATER WHILE STILL ON ACTIVITY RESTRICTION PROTOCOL (BEDREST), PT EXPERIENCED BLEEDING FROM SITE AND WARRANTED MANUAL PRESSURE ON FEMORAL ARTERY UNTIL BLEEDING SUBSIDED. POST PROCEDURE ACTIVITY RESTRICTION PROTOCOL (INCLUDING 3 HOURS FLAT ON BACK AND TWO ADDITIONAL HOURS BEDREST) RE-INITIATED. PT DISCHARGED ON (B) (6) 2010 WITHOUT COMPLICATIONS OR ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMCON PATCH HEMOSTATIC DRESSING (EXTERNAL) FRO HEMCON MEDICAL TECHNOLOGIES, INC. 10-129-002

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other