BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKCLOT

    MDR report key: 1519983 · Received October 28, 2009

    Report

    Report Number
    MW5013210
    Event Type
    Injury
    Date Received
    October 28, 2009
    Report Date
    October 28, 2009
    Manufacturer
    Z-MEDICA CORPORATION
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    THE FACILITY HAS FINALIZED ITS OPINION OF A GRANULAR/POWDERED HEMOSTATIC AGENT, QUICKCLOT -QC- ORIGINAL FORMULA. BASED ON NEW RETROSPECTIVE REVIEWS AND SAFETY STUDIES OF THESE AGENTS, THE STUDIES HAVE DEMONSTRATED THAT WHEN MAJOR VESSEL HEMORRHAGE WOUNDS ARE TREATED WITH PROCOAGULANT GRANULAR/POWDERED HEMOSTATIC AGENTS/DRESSINGS, TREATMENT CAN RESULT IN DISTAL THROMBUS FORMATION AND/OR EMBOLIC EVENTS IN DISTAL ORGANS WHICH IS LIFE THREATENING. SEVERAL EFFICACY/SAFETY STUDIES HAVE RECENTLY BEEN CONCLUDED AND ARE AWAITING PUBLICATION. THESE REPORTS OUTLINE THE POTENTIAL RISKS OF EMBOLISM WITH PROCOAGULANT GRANULAR/POWDERED HEMOSTATIC AGENTS/DRESSINGS. "ALL GRANULAR AGENTS WILL HAVE THE THEORETICAL RISK OF EMBOLISM." ADDITIONALLY, THE ORIGINAL QC WAS PREVIOUSLY TESTED ON GROIN VASCULAR INJURY IN SWINE WHICH RESULTED IN TISSUE NECROSIS AND ABSCESS OF THE WOUND AFTER ONE TO FOUR WEEKS RECOVERY. -WOUNDS WERE FULLY DEBRIDED PRIOR TO CLOSURE.- THE CHANGES WERE ATTRIBUTED TO THE THERMAL INJURY OF THE PRODUCT. BASED ON ALL AVAILABLE DATA ON THESE AGENTS USE, THE CLINICAL RECOMMENDATION IS: IMMEDIATELY DISCONTINUE USE OF ORIGINAL QUICKCLOT. THIS PRODUCT IS NO LONGER MANUFACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKCLOT HEMOSTATIC AGENT, TRAUMATIC WOUND DRESSING FRO Z-MEDICA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| R| S