BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QC CONTROL+, 3IN X 2YD, Z-FOLD, 10X

    MDR report key: 24495365 · Received March 3, 2026

    Report

    Report Number
    3004138549-2026-00002
    Event Type
    Injury
    Date Received
    March 3, 2026
    Date of Event
    January 27, 2026
    Report Date
    February 4, 2026
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    POD
    PMA / PMN Number
    K220971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). IFU WARNINGS SECTION CLEARLY STATES: PRODUCT IS NOT ABSORBABLE AND MUST BE REMOVED FROM WOUND PRIOR TO WOUND CLOSURE. A TWO-YEAR LOOKBACK FOUND LIKE COMPLAINTS IN ADDITION TO THE ONE NOTED ABOVE. ALL WERE ATTRIBUTABLE TO USER ERROR (NOT FOLLOWING IFU) , NO FAILURES OF PRODUCT PERFORMANCE OR PRODUCT LABELING WERE FOUND. CONTRAINDICATIONS SECTION CLEARLY STATES: DO NOT LEAVE QUIKCLOT CONTROL+ IN PLACE FOR MORE THAN 48 HOURS. IFU INSTRUCTIONS ADEQUATELY ESTABLISH THE NEED TO REMOVE THE PRODUCT PRIOR TO WOUND CLOSURE. THIS EVENT WAS THE RESULT OF THE USER NOT FOLLOWING PRODUCT IFU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THERE WAS A PATIENT IDENTIFIED WITH CONTROL+ LEFT INSIDE A PATIENT AND THEY WAS BROUGHT BACK TO THE OPERATING ROOM YESTERDAY FOR REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303510 QC CONTROL+, 3IN X 2YD, Z-FOLD, 10X TEMPORARY, INTERNAL USE HEMOS POD Z-MEDICA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED