BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIK CLOT CONTROL + 5X5

    MDR report key: 10069615 · Received May 18, 2020

    Report

    Report Number
    MW5094533
    Event Type
    Malfunction
    Date Received
    May 18, 2020
    Date of Event
    March 26, 2020
    Report Date
    May 14, 2020
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER THE Z-MEDICA, LLC. PRODUCT REPRESENTATIVE, SOME OF THE QUIK CLOT PRODUCTS ARE INTENDED TO BE USED EXTERNALLY ONLY. THESE PRODUCT LABELS DO NOT REFLECT THAT INDICATION ON THE LABEL. THE LABEL DOES NOT STATE "FOR EXTERNAL USE ONLY". OTHER QUIK CLOT PRODUCTS ARE INDICATED FOR INTERNAL USE. THOSE PRODUCT LABELS DO NOT INDICATE THAT THEY ARE INTENDED TO BE USED INTERNALLY ONLY. THE PRODUCTS LABELS DO NOT CLEARLY DELINEATE HOW THE MANUFACTURER HAS INTENDED FOR THE PRODUCT TO BE USED. QUIK CLOT PRODUCTS ARE LABELED AS X-RAY DETECTABLE. PRODUCTS THAT ARE X-RAY DETECTABLE ARE MADE WITH RADIOPAQUE PORTIONS WHICH ALLOWS THE PRODUCT TO BE IDENTIFIED BY X-RAY TO PREVENT RETENTION OF FOREIGN BODIES. QUIK CLOT PRODUCTS ARE DESIGNED WITH RADIOPAQUE MATERIAL TO ALLOW THE PRODUCT TO BE IDENTIFIED BY X-RAY. THE QUIK CLOT CONTROL + 5X5 PRODUCT HAS A MINIMAL PORTION OF RADIOPAQUE MATERIAL WHICH MAY IMPACT ITS ABILITY TO BE DETECTED UPON X-RAY. THE PRODUCT MAY BE IMPROVED BY INCREASING THE RADIOPAQUE PORTIONS TO MAKE THEM X-RAY DETECTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531966 QUIK CLOT CONTROL + 5X5 DRESSING, WOUND, DRUG FRO Z-MEDICA, LLC
    531968 QUIK CLOT CONTROL + 5X5 DRESSING, WOUND, DRUG FRO Z-MEDICA, LLC 10320
    531969 QUIK CLOT CONTROL + 5X5 DRESSING, WOUND, DRUG FRO Z-MEDICA, LLC
    531970 QUIK CLOT CONTROL + 5X5 DRESSING, WOUND, DRUG FRO Z-MEDICA, LLC
    531971 QUIK CLOT CONTROL + 5X5 DRESSING, WOUND, DRUG FRO Z-MEDICA, LLC
    531972 QUIK CLOT HEMOSTATIC DRESSING DRESSING, WOUND, DRUG FRO Z-MEDICA, LLC. 11040
    531973 QUIK CLOT HEMOSTATIC DRESSING DRESSING, WOUND, DRUG FRO Z-MEDICA, LLC. 10752

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other