BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC CONTROL+, 5" X 5" 4-PLY, 10X

    MDR report key: 19977445 · Received August 13, 2024

    Report

    Report Number
    3011137372-2024-00125
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    April 15, 2024
    Report Date
    July 23, 2024
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    POD
    PMA / PMN Number
    K220971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. NO LOT / BATCH NUMBER COULD BE PROVIDED BY COMPLAINANT SO A DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED "CALL RECEIVED FROM A PATIENT WHO STATED HER DOCTOR CALLED HER IN FOR A FOLLOW UP VISIT AND TOLD HER SHE USED A DRESSING TO CONTROL BLEEDING DURING HER SURGERY THAT IS NOT ABSORBED AND SHE HAS TO REMOVE IT. PATIENT STATED SHE HAD BREAST SURGERY 3 MONTHS AND HAD A 2ND SURGERY ON (B)(6) 2024 TO REMOVE THE DRESSING. THE SURGEON TOLD HER SHE BELIEVES SHE GOT MOST OF IT BUT SOME SMALL PIECES MAY HAVE BEEN LEFT BEHIND DUE TO THE LOCATION AND MUSCLE GROWTH." THE QUICK CLOT WAS REMOVED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639528 QC CONTROL+, 5" X 5" 4-PLY, 10X TEMPORARY, INTERNAL USE HEMOS POD Z-MEDICA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED