BEUDAMED
    FDA Adverse Event Death Summary report: N

    QC HEMOSTATIC DRESSING, 2X2, 10X

    MDR report key: 21803577 · Received April 9, 2025

    Report

    Report Number
    3011137372-2025-00105
    Event Type
    Death
    Date Received
    April 9, 2025
    Date of Event
    September 1, 2024
    Report Date
    March 13, 2025
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    QSY
    PMA / PMN Number
    K123387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) NO ITEM RETURNED FOR EVALUATION. IFU WARNINGS SECTION CLEARLY STATES:1) PRODUCT IS NOT ABSORBABLE AND MUST BE REMOVED FROM WOUND PRIOR TO WOUND CLOSURE.2) THE QUIKCLOT HEMOSTATIC DRESSING MUST NOT REMAIN IN THE WOUND FOR LONGER THAN 24 HOURS. THIS COMPLAINT IS THE RESULT OF USER ERROR, NOT ADHEARING TO IFU INSTRUCTIONS AND WARNINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THE PATIENT UNDERWENT SURGERY IN (B)(6) 2024 TO REMOVE A HEMOSTATIC DRESSING THAT HAD BEEN LEFT IN THE BODY DURING ANOTHER SURGERY ON (B)(6) 2022. THE HEMOSTATIC DRESSING HAD CAUSED AN ABSCESS TO FORM AND LED TO A SEVERE INFECTION, AND UNFORTUNATELY, THE PATIENT DIED." ADDITIONAL INFORMATION HAS BEEN REQUESTED AND A FOLLOW UP REPORT WILL BE SUBMITTED IF IT IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422376 QC HEMOSTATIC DRESSING, 2X2, 10X DRESSING, WOUND, DRUG QSY Z-MEDICA, LLC 44F21L0003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death NOT REPORTED