BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC HEMOSTATIC DRESSING, 4X4, 10X

    MDR report key: 19653746 · Received July 2, 2024

    Report

    Report Number
    3011137372-2024-00092
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 5, 2024
    Report Date
    June 5, 2024
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    FRO
    UDI-DI
    00841495104596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UDI NUMBER UNAVAILABLE AS COMPLAINANT DID NOT REPORT A LOT NUMBER. THE SAMPLE WAS NOT RETURNED FOR INVESTIGATION. IT CANNOT BE ESTABLISHED IF THE CUSTOMER WAS USING A QUIKCLOT PRODUCT OR QUIKCLOT CONTROL+ PRODUCT. BASED ON THIS A REVIEW OF BOTH PRODUCT FAMILY IFUS WERE REVIEWED. ALL QUIKCLOT PRODUCT IFUS STATE THE PRODUCT INTENDED USE IS A TOPICAL DRESSING, MUST NOT REMAIN IN THE WOUND FOR LONGER THAN 24 HOURS, AND NOT FOR USE IN INTERNAL SURGICAL PROCEDURES. ALL QUIKCLOT CONTROL+ PRODUCT IFUS STATE IT IS INTENDED FOR TEMPORARY CONTROL OF INTERNAL ORGAN BLEEDING, IT MAY ALSO BE USED FOR CONTROL OF SURGICAL WOUNDS, AND DO NOT LEAVE IN PLACE FOR MORE THAN 48 HOURS. USER DID NOT FOLLOW IFU. REVIEW OF IFUS SHOW PRODUCT WAS NOT USED PROPERLY AS CONTAINED IN INDICATIONS FOR USE. (B)(4) WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: QUICK CLOT WAS LEFT IN PATIENT FOR A YEAR AND WAS FOUND ON MRI AND MAMMOGRAM. PROVIDER WAS CALLING ABOUT INFORMATION WE HAVE ON LEAVING THE PRODUCT INTERNAL IN A PATIENT FOR EXTENDED AMOUNT OF TIME. I INFORMED HER OF THE IFU WE FOLLOW AND PRODUCT GUIDELINES WE TEACH. FOLLOW UP WAS PROVIDED FROM DAN SMITH AND PROVIDER WAS ADVISED TO REMOVE THE PRODUCT SINCE WE DONT HAVE ANY LITERATURE TO SUPPORT LONG TERM PLACEMENT OF THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684851 QC HEMOSTATIC DRESSING, 4X4, 10X DRESSING, WOUND, DRUG FRO Z-MEDICA, LLC 00841495104596

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown