BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC HEMO DRESSING 4"X4",MULTI-LANG,CE,10X

    MDR report key: 22344145 · Received June 27, 2025

    Report

    Report Number
    3004138549-2025-00004
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    May 30, 2025
    Report Date
    June 4, 2025
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    FRO
    UDI-DI
    10841495150286
    PMA / PMN Number
    K123387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN #: (B)(4). BASED UPON THE FINDINGS CONTAINED IN THIS COMPLAINT REVIEW IT DOES NOT APPEAR THAT THE ITEM HAD THE POTENTIAL FOR INABILITY TO PERFORM AS INTENDED. IN THE IFU IT STATES "APPLY DRESSING DIRECTLY TO THE SOURCE OF THE BLEEDING AND USE IT TO APPLY MANUAL COMPRESSION.... MORE THAN ONE DRESSING MAY BE REQUIRED....CONTINUE TO APPLY MANUAL PRESSURE FOR 5 MINUTES, OR UNTIL BLEEDING IS CONTROLLED." BASED UPON THE CUSTOMER REPLY STATING THE "PATIENT WAS LYING IN A POOL OF BLOOD" POSSIBLY INDICATES THAT THE HEMOSTATIC BANDAGE WAS NOT USED PER IFU. DHR REVIEW FOUND NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, "PATIENT'S PERMCATH INSERTION SITE WAS BLEEDING AND THE QUIKCLOT DID NOT HELP TO STOP THE BLEEDING. PATIENT IS STILL IN SURGICAL WARD; BLEEDING IS CURRENTLY UNDER CONTROL. IT LOOKS LIKE THE BLEEDING OCCURRED IN ICU OVER THE WEEKEND. THE DOCTOR GAVE SOMETHING TO STOP HELP STOP THE BLEEDING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813288 QC HEMO DRESSING 4"X4",MULTI-LANG,CE,10X DRESSING, WOUND, DRUG FRO Z-MEDICA, LLC 44F23L0004 10841495150286

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED