BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QC ROLL HEMOSTATIC DRESSING,10X

    MDR report key: 20877821 · Received December 9, 2024

    Report

    Report Number
    3011137372-2024-00189
    Event Type
    Injury
    Date Received
    December 9, 2024
    Date of Event
    October 31, 2024
    Report Date
    November 19, 2024
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    QSY
    PMA / PMN Number
    K123387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FULL UDI IS NOT AVAILABLE AS THE LOT# WAS NOT PROVIDED BY THE CUSTOMER. NO SAMPLE RETURNED FOR EVALUATION A TWO-YEAR LOOKBACK ON DEVICE HISTORY RECORDS FOUND TWO LIKE COMPLAINTS. BOTH WERE ATTRIBUTABLE TO USER ERROR; NO FAILURE OF PRODUCT OR LABELING WAS FOUND. LOT NUMBER WAS NOT COMMUNICATED BY COMPLAINANT. IFU WARNINGS CLEARLY STATE: 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 IN ADDITION, THE COMPLAINANT NOTED THEY DID NOT FOLLOW INSTRUCTIONS. THIS COMPLAINT IS THE RESULT OF USER ERROR AS CONFIRMED BY COMPLAINANT. IFU WAS NOT FOLLOWED, IFU WARNINGS WERE NOT ADHEARED BY COMPLAINANT.

    Description of Event or Problem · 0

    QCNI ROLL WAS BELIEVED TO BE PACKED IN A PATIENT'S LEG FASCIOTOMY WOUND IN THE ICU. UPON PATIENT'S RETURN FOR A GRAFT ROUGHLY FIVE MONTHS LATER, AN INFECTION WAS IDENTIFIED IN THE LEG. THE DOCTOR IDENTIFIED UPON PATHOLOGY REPORT THAT QUIKCLOT WAS STILL INSIDE OF THE LEG. THE QUIKCLOT WAS REMOVED ONCE IDENTIFIED, AND THE PATIENT WAS TREATED FOR THE INFECTION WITH ANTIBIOTICS AND THE INFECTION CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328402 QC ROLL HEMOSTATIC DRESSING,10X DRESSING, WOUND, DRUG QSY Z-MEDICA, LLC UNKNOWN

    Patients

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