BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QC Z-FOLD HEMOSTATIC DRESSING,10X

    MDR report key: 20217560 · Received September 13, 2024

    Report

    Report Number
    3004138549-2024-00001
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    May 1, 2024
    Report Date
    August 13, 2024
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FRO
    PMA / PMN Number
    K123387
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON FURTHER REVIEW IT WAS DETERMINED THAT THIS WAS NOT A REPORTABLE EVENT, THUS, THE INITIAL MDR SUBMITTED ON 09/13/2024 SHOULD BE RETRACTED.

    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

    Description of Event or Problem · 0

    IT WAS REPORTED "DURING THE FIRST COUNT, IT WAS DISCOVERED THAT THERE WAS A QUICK CLOT GAUZE PIECE WAS MISSING. THE SURGICAL FIELD, SURGICAL INCISION, AS WELL AS OUTSIDE OF THE SURGICAL FIELD, ON THE FLOOR, IN THE TRASH CANS, AND UNDER EQUIPMENT WAS SEARCHED. THE QUICK CLOT PIECE WAS NOT FOUND, AND X-RAY WAS CALLED TO COME FOR A FLATPLATE. RADIOLOGIST READ THE X-RAY AS NEGATIVE, AND THIS RESULT WAS COMMUNICATED TO ALL STAFF IN THE ROOM. SURGEON FELT IT WAS APPROPRIATE TO EXPLORE WOUND, SURGICAL SITE REOPENED AT WHICH POINT QUICK GAUZE WAS FOUND AND REMOVED". THE PRODUCTS ARE ALL CURRENTLY LABELED AS "X-RAY DETECTABLE. WHEN THE X-RAY WAS PERFORMED, THIS PRODUCT WAS NOT SEEN ON THE FILM". WHEN ASKED ABOUT THE PATIENT'S CURRENT CONDITION IT WAS REPORTED THAT " THE PATIENT WAS DISCHARGED HOME 4 DAYS LATER, AS EXPECTED. NO COMPLICATIONS NOTED FROM SURGERY".

    Description of Event or Problem · 0

    IT WAS REPORTED "DURING THE FIRST COUNT, IT WAS DISCOVERED THAT THERE WAS A QUICK CLOT GAUZE PIECE WAS MISSING. THE SURGICAL FIELD, SURGICAL INCISION, AS WELL AS OUTSIDE OF THE SURGICAL FIELD, ON THE FLOOR, IN THE TRASH CANS, AND UNDER EQUIPMENT WAS SEARCHED. THE QUICK CLOT PIECE WAS NOT FOUND, AND X-RAY WAS CALLED TO COME FOR A FLATPLATE. RADIOLOGIST READ THE X-RAY AS NEGATIVE, AND THIS RESULT WAS COMMUNICATED TO ALL STAFF IN THE ROOM. SURGEON FELT IT WAS APPROPRIATE TO EXPLORE WOUND, SURGICAL SITE REOPENED AT WHICH POINT QUICK GAUZE WAS FOUND AND REMOVED". THE PRODUCTS ARE ALL CURRENTLY LABELED AS "X-RAY DETECTABLE. WHEN THE X-RAY WAS PERFORMED, THIS PRODUCT WAS NOT SEEN ON THE FILM". WHEN ASKED ABOUT THE PATIENT'S CURRENT CONDITION IT WAS REPORTED THAT " THE PATIENT WAS DISCHARGED HOME 4 DAYS LATER, AS EXPECTED. NO COMPLICATIONS NOTED FROM SURGERY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113396 QC Z-FOLD HEMOSTATIC DRESSING,10X DRESSING, WOUND, DRUG FRO TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown