BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z-MEDICA QUIKCLOT 4X4 XRAY (PROD #459)

    MDR report key: 4869401 · Received June 22, 2015

    Report

    Report Number
    MW5043228
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 4, 2015
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT PRESENTED TO TRAUMA CENTER WITH RIGHT CHEST STAB WOUND AND SUBCLAVIAN ARTERY TRANSECTION. Z-MEDICA QUIKCLOT 4X4 X-RAY (PROD #459) WAS PACKED IN STAB WOUND AND PATIENT BROUGHT TO OPERATING ROOM AND STERNOTOMY AND ARTERIAL REPAIR PERFORMED. POSTOPERATIVELY, PACKING SHOULD HAVE BEEN REMOVED WITHIN 24 HOURS BUT WAS OVERLOOKED. DESPITE RADIO-OPAQUE MARKER IN QUIKCLOT DRESSING, PRESENCE OF DRESSINGS IN STAB WOUND WAS NOT IDENTIFIED ON 20 SUBSEQUENT CHEST X-RAYS AND 4 CT CHEST SCANS. PATIENT WAS READMITTED TWICE WITH DRAINAGE AND ABSCESS AT STAB WOUND UNTIL DRESSINGS FOUND AND REMOVED AT INCISION AND DRAINAGE 73 DAYS AFTER INSERTION. RETROSPECTIVE REVIEW OF IMAGING INDICATE THE RADIO-OPAQUE MARKER IN THE QUIKCLOT 4X4 X-RAY DRESSINGS WERE VISIBLE ON SOME X-RAYS. HOWEVER THE MARKER IS CONSIDERABLE FAINTER AND THINNER THAN RADIO-OPAQUE MARKERS USED IN TRADITIONAL OPERATING ROOM SURGICAL SPONGES, MAKING THE DRESSING MORE DIFFICULT TO IDENTIFY ON PLAIN RADIOGRAPHY AND CT SCANNING. RECOMMEND A MORE VISIBLE RADIO-OPAQUE MARKER DUE TO THE RISK OF LEAVING THIS PRODUCT IN TRAUMATIC WOUNDS. ALSO SUGGEST ONLY LARGE FORMAT DRESSINGS BE USED FOR PACKING, SUCH AS ROLLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402291 Z-MEDICA QUIKCLOT 4X4 XRAY (PROD #459) QUIKCLOT FRO Z-MEDICA, LLC 459

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization