BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUIKCLOT HEMOSTATIC DRESSING

    MDR report key: 11343828 · Received February 17, 2021

    Report

    Report Number
    MW5099466
    Event Type
    Injury
    Date Received
    February 17, 2021
    Date of Event
    November 17, 2020
    Report Date
    February 15, 2021
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    QUIKCLOT WAS RETAINED INTERNALLY IN THE PATIENT'S LEG AFTER BEING APPLIED TO AN OPEN FASCIOTOMY OF THE RIGHT CALF ON (B)(6) 2020. THE PATIENT UNDERWENT SURGERIES ON (B)(6) TO REMOVE THE QUIKCLOT GAUZE AND PACKING FIBERS BECAUSE IT WAS STUCK IN THE DEEPER TISSUE AND HAD DISINTEGRATED INTO SMALL PIECES. THE QUIKCLOT WAS IDENTIFIED THROUGH AN MRI, AND THE FOREIGN MATERIAL THAT WAS VISIBLE TO THE SURGEON WAS COMPLETELY REMOVED. THE LABEL ON THE QUIKCLOT PACKAGE DOES NOT MENTION IT IS FOR 24 HOUR USE, WHICH COULD HAVE LED TO THIS USER ERROR. IT IS PRINTED ON THE MIFU, WHICH IS DISCARDED BEFORE SUPPLY TECHNICIANS PLACE THE PRODUCT ON SHELVES. FURTHER, MORE SPECIFIC LABELING IS RECOMMENDED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236259 QUIKCLOT HEMOSTATIC DRESSING DRESSING, WOUND, DRUG FRO Z-MEDICA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other