BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21065101 · Received January 3, 2025

    Report

    Report Number
    3011137372-2025-00004
    Event Type
    Injury
    Date Received
    January 3, 2025
    Date of Event
    December 6, 2024
    Report Date
    December 9, 2024
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    POD
    UDI-DI
    10841495150026
    PMA / PMN Number
    K220971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    TRAUMA PATIENT CAME IN FROM CAR ACCIDENT. QC C+ WAS USED TO PACK LIVER BLEED, PATENT WENT TO ICU AND NEXT DAY WENT TO X-RAY. RADIOLOGIST WAS NOT AWARE OF QC BEING LEFT IN THE PATIENT AND COULD NOT SEE ANY DETECTION AT FIRST PASS/INITIAL READ. PRODUCT WAS LEFT IN PATIENT AND RADIOLOGIST TOOK A SECOND LOOK AND WAS ABLE TO SEE THE X-RAY DETECTABLE STRIP THE SECOND TIME. PRODUCT WAS IN FOR AT LEAST 24 HRS. ALL PRODUCT WAS REMOVED AT THIS TIME. SOUNDS LIKE THERE IS NO PATIENT HARM. THE PATIENT RETURNED TO SURGERY AFTER IT WAS DISCOVERED THE Z-FOLD WAS LEFT IN PLACE INADVERTENTLY. THEY RETURNED TO SURGERY AND IT WAS REMOVED SUCCESSFULLY. THE CONCERN WAS THAT THE Z-FOLD IS NOT EASILY RECOGNIZABLE ON AN XRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457831 QC CONTROL+, 3" X 2 YD Z-FOLD, 10X TEMPORARY, INTERNAL USE HEMOS POD Z-MEDICA, LLC 44F24F0019 10841495150026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED.