BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUIKCLOT

    MDR report key: 3006620 · Received March 11, 2013

    Report

    Report Number
    3004138549-2013-00001
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 4, 2013
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    FRO
    PMA / PMN Number
    K072474
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE WHO REPORTED THE INCIDENT NOTED THAT THE QUIKCLOT DEVICE WORKED PROPERLY, STOPPING BLEEDING, AND THERE WAS NOTHING WRONG WITH THE PRODUCT. SHE REPORTED THAT THE HOSPITAL CONCLUDED THIS INCIDENT WAS THE RESULT OF INTERNAL COMMUNICATION AND DOCUMENTATION ISSUES WITHIN THE HOSPITAL RESULTING IN ONE OF THE QUIKCLOT DEVICE BEING LEFT IN THE WOUND. THE LABEL STATES THE DEVICE IS FOR TEMPORARY EXTERNAL USE TO CONTROL TRAUMATIC BLEEDING. THE LABEL ALSO SPECIFIES THE DEVICES ARE TO BE ONLY LEFT IN PLACE FOR UP TO 24 HOURS. IN CONCLUSION THE PRODUCT FUNCTIONED PROPERLY AND STOPPED THE BLEEDING. THE DEVICE WAS INADVERTENTLY LEFT IN THE WOUND DUE TO USER ERRORS RELATED TO COMMUNICATION AND DOCUMENTATION. THE INSTRUCTIONS FOR USE STATE THAT THE DEVICE CANNOT BE LEFT IN PLACE FOR MORE THAN 24 HOURS.

    Description of Event or Problem · 1

    PATIENT ADMITTED TO HOSPITAL WITH 12 GUNSHOT WOUNDS IN CHEST AND ABDOMEN. THE DOCTOR USED 2 LAP PADS (FROM ANOTHER MANUFACTURER) AND 2 QUIKCLOT DEVICES TO PACK THE WOUNDS IN THE ABDOMEN. THE PADS WERE LEFT IN THE WOUNDS OVERNIGHT (NOT UNUSUAL AND WITHIN SCOPE) IN ORDER TO EVALUATE THE EXTENT OF INJURIES. EIGHTEEN HOURS LATER THE PATIENT WAS BROUGHT TO THE OPERATING ROOM. A DIFFERENT PHYSICIAN REMOVED TWO OF THE LAP PADS AND ONE OF THE QUIKCLOT DEVICES, AND THEN CLOSED THE WOUNDS. FOUR TO FIVE DAYS FOLLOWING THE SURGERY, THE PATIENT WENT INTO SEPTIC SHOCK. A PHYSICIAN IDENTIFIED VIA X-RAY SCAN THAT A QUIKCLOT HAD BEEN LEFT IN THE WOUND. THE PHYSICIAN BROUGHT THE PATIENT TO THE OPERATING ROOM AND REMOVED THE REMAINING QUIKCLOT. THE NURSE WHO REPORTED THE INCIDENT NOTED THAT THE PATIENT WAS IN STABLE CONDITION BUT REMAINED IN INTENSIVE CARE. ALTHOUGH THE INCIDENT WAS DIRECTLY RELATED TO USER ERROR AND NOT DIRECTLY RELATED TO THE DEVICE, THIS IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102443 QUIKCLOT HEMOSTATIC WOUND DRESSING FRO Z-MEDICA, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention