BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMCON PATCH

    MDR report key: 1726889 · Received June 14, 2010

    Report

    Report Number
    MW5016371
    Event Type
    Malfunction
    Date Received
    June 14, 2010
    Date of Event
    May 25, 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, FOLLOWED BY WITH A HEMCON PATCH AND MANUAL PRESSURE. APPROX, 3 HOURS POST SHEATH REMOVAL WHILE PT WAS STILL ON ACTIVITY RESTRICTIONS/ BEDREST, HEAD-OF-BED WAS ELEVATED TO EAT AND PT EXPERIENCED "HURTING" IN RIGHT GROIN. UPON INSPECTION OF RIGHT GROIN, LARGE HEMATOMA, "PAINFUL TO TOUCH" WAS NOTED. THE PT WAS POSITIONED IN TRENDELENBURG FOR BP CONTROL AND MANUAL PRESSURE WAS RE-APPLIED TO RIGHT FEMORAL ARTERY GROIN UNTIL BLEEDING SUBSIDED. THE PT WAS DISCHARGED HOME ON (B) (6) 2010 WITHOUT ANY ADDITIONAL 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 58 YR Other