BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMCON PATCH

    MDR report key: 1726894 · Received June 14, 2010

    Report

    Report Number
    MW5016372
    Event Type
    Malfunction
    Date Received
    June 14, 2010
    Date of Event
    May 26, 2010
    Report Date
    June 1, 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 PROCEDURE, RIGHT GROIN SHEATH WAS REMOVED, HEMCON PATCH AND MANUAL PRESSURE APPLIED FOR APPROX 25 MINS FOLLOWED BY A SANDBAG TO SITE AND BEDREST. APPROX, 2 1/2 HOURS POST SHEATH REMOVAL, PT WAS TRANSFERRED PER CART TO UNIT BED. AT THAT TIME, PT USED BEDPAN TO VOID AND EXPERIENCED RE-BLEEDING AT SITE. THIS WARRANTED MANUAL PRESSURE ON RIGHT FEMORAL ARTERY UNTIL BLEEDING SUBSIDED. RESUMED ACTIVITY RESTRICTION (BEDREST) WITH HOB NO GREATER THAN 15 DEGREES AND MOBILITY RESTRICTION OF RIGHT LEG. THE PT WAS DISCHARGED HOME ON (B) (6) 2010 WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMCON PATCH HEMOSTATIC DRESSING (EXTERNAL) FRO HEMCON MEDICAL TECHNOLOGIES, INC. HEM260 HEMCON PATCH 10-129-002 OR 003 OR 004(UNK)

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other