BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUIKCLOT 4X4 HEMOSTATIC DRESSING

    MDR report key: 5591355 · Received April 20, 2016

    Report

    Report Number
    3004138549-2016-00001
    Event Type
    Injury
    Date Received
    April 20, 2016
    Date of Event
    March 18, 2016
    Report Date
    April 8, 2016
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    FRO
    PMA / PMN Number
    K123387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED ISSUES IN REGARDS TO PRODUCT PERFORMANCE AND THERE WERE NO FAILURES OR DEFECTS EXPERIENCED WITH THE PRODUCT. THE INSTRUCTIONS FOR USE WARNINGS SECTION SPECIFIES THAT "THE QUIKCLOT HEMOSTATIC DRESSING MUST NOT REMAIN IN THE WOUND FOR LONGER THAN 24 HOURS". THIS IS FURTHER SUPPLEMENTED IN THE ACTUAL INSTRUCTIONS WHICH STATE "THE HEMOSTATIC DRESSING MAY BE LEFT IN PLACE FOR UP TO 24 HOURS". WE CAN ONLY SPECULATE THAT THE HOSPITAL MISTAKENLY BELIEVED THAT THE HEMOSTATIC DRESSING WAS REMOVED FROM THE WOUND. IN CONCLUSION, THERE IS NO EVIDENCE OF ANY PROBLEMS OR DEFICIENCIES IN REGARDS TO THE QUIKCLOT HEMOSTATIC DRESSING AND THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELING. DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE PATIENT WAS AT THE HOSPITAL FOR TREATMENT BECAUSE OF A DIABETIC ULCER WOUND ON THE FOOT. A QUIKCLOT 4X4 HEMOSTATIC DRESSING WAS USED TO STOP THE BLEEDING. ON (B)(6) 2015 THE NURSE DECIDED NOT TO DISTURB THE WOUND AND LEFT THE QUIKCLOT 4X4 HEMOSTATIC DRESSING IN PLACE. ON (B)(6) 2015 THE PATIENT RETURNED FOR A FOLLOW UP VISIT. THE NOTES FROM THE NURSE ON DUTY INDICATED THAT THE QUIKCLOT 4X4 HEMOSTATIC DRESSING WAS REMOVED. ON (B)(6) 2016 THE PATIENT RETURNED TO THE FACILITY COMPLAINING THAT THE WOUND HAD NOT HEALED. UPON X-RAY EXAMINATION, IT REVEALED THAT THE QUIKCLOT 4X4 HEMOSTATIC DRESSING REMAINED IN THE WOUND. THE GAUZE WAS REMOVED FROM THE WOUND. THE HOSPITAL HAS INDICATED THAT THERE WERE NO ISSUES WITH THE QUIKCLOT 4X4 HEMOSTATIC DRESSING AND ACKNOWLEDGED THAT THE PRODUCT WAS LEFT IN PLACE LONGER THAN THE TIMEFRAME SPECIFIED IN THE LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248220 QUIKCLOT 4X4 HEMOSTATIC DRESSING HEMOSTATIC WOUND DRESSING FRO Z-MEDICA, LLC 459 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention