BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QC HEMOSTATIC DRESSING, 4X4, 10X

    MDR report key: 21651039 · Received March 20, 2025

    Report

    Report Number
    3011137372-2025-00090
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    January 8, 2025
    Report Date
    February 27, 2025
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    QSY
    PMA / PMN Number
    K123387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FULL UDI NOT AVAILABLE AS THE LOT# WAS NOT PROVIDED BY THE CUSTOMER. SAMPLE WAS NOT RETURNED FOR INVESTIGATION. IFU WARNINGS SECTION CLEARLY STATES: PRODUCT IS NOT ABSORBABLE AND MUST BE REMOVED FROM WOUND PRIOR TO WOUND CLOSURE. THE QUIKCLOT HEMOSTATIC DRESSING MUST NOT REMAIN IN THE WOUND FOR LONGER THAN 24 HOURS. ADDITIONALLY, THE CUSTOMER NOTED THEY ARE NOT SURE THE FOREIGN MATERIAL IS ACTUALLY A QUIKCLOT PRODUCT. THERE IS NO IDENTIFIED PRODUCT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "FOREIGN PRODUCT LEFT IN A PATIENT THAT IS SUSPECTED TO BE A 4X4 QUIKCLOT. PATHOLOGY ASSISTANT COULD NOT DETERMINE EXACTLY WHAT THE FOREIGN OBJECT WAS. PRODUCT WAS LEFT IN THE BODY FROM 1/8 TILL 2/14 AFTER A PACEMAKER PROCEDURE. THE PATIENT DID COMPLAIN OF CHEST PAINS. 3 X-RAYS PERFORMED BUT NOTHING WAS DETECTED. PATIENT HAD CHEST WALL HEMATOMA. AFTER REVIEWING CASE, THEY SUSPECTED THE FINAL COUNT FAILED BECAUSE OF A MID-OPERATION SWITCH OF PROVIDERS WITH AN ABSENCE OF A CONFIRMED COUNT BEFORE THE SECOND OPERATION BEGAN. SURGERY WAS PERFORMED. THEY ARE NOT CONTRIBUTING THIS AS A PRODUCT FAULT BUT TO USER AND PROCESS ERROR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306559 QC HEMOSTATIC DRESSING, 4X4, 10X DRESSING, WOUND, DRUG QSY Z-MEDICA, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention NOT REPORTED.