BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URESIL, LLC

    MDR report key: 1950485 · Received December 28, 2010

    Report

    Report Number
    MW5018751
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 22, 2010
    Report Date
    December 28, 2010
    Manufacturer
    URESIL, LLC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I WOULD LIKE TO REPORT AN UNEXPECTED COMPLICATION ARISING FROM FRACTURED METAL STIFFENING CANNULA OF DRAINAGE CATHETER DURING CATHETER PLACEMENT IN TO INTRA-ABDOMINAL ACID. THERE ARE REPORTS RELATED WITH GUIDE-WIRE FRACTURE IN THE MEDICAL LITERATURE. HOWEVER, AS WE KNOW, THERE IS NOT ANY REPORT ABOUT FRACTURING OF METAL STIFFENING CANNULA. (B)(6) OBESE WOMAN WITH MASSIVE INTRA-ABDOMINAL ACID WAS ADMITTED TO PLACEMENT A DRAINAGE CATHETER. WE TRIED TO PLACE A 8F HYDROPHILIC-COATED DRAINAGE CATHETER -URESIL, LLC., (B)(4)- IN TO ACID AFTER SKIN NICK AND PERFORATED SUBCUTANEOUS TISSUE USING TROCAR TECHNIQUE. FIRST THE SKIN AND FATTY TISSUE WERE PASSED, AFTER THAT WE TRIED TO PASS FASCIA, BUT WE FAILED. WE TOOK BACK THE CATHETER DUE TO UNSUCCESSFUL PLACEMENT. WE NOTICED FRACTURING OF THE TIP OF METAL STIFFENING CANNULA -6.5 CM IN LENGTH-. THE BROKEN, CURVED PART WAS IN THE DRAINAGE CATHETER. FORTUNATELY, ANY SERIOUS COMPLICATION DID NOT OCCUR, SECOND SAME CATHETER PLACED WITHOUT ANY COMPLICATION. I HAVE SENT AN EMAIL TO " (B)(4) URESIL, LLC". I SENT THE PHOTOS OF CATHETER AND CANNULA AS WELL. THEY SAID TO ME: "WE NEED TO HAVE THE PRODUCT BACK SO WE CAN DETERMINE THE CAUSE. THIS A RATHER UNUSUAL SITUATION SINCE IT HAS NEVER HAPPENED BEFORE". PRODUCT IS AVAILABLE NOW, BUT URESIL, LLC. WANTED WHICH I SEND, SO I WILL SEND IT TO URESIL LLC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URESIL, LLC DRAINAGE CATHETER FGE URESIL, LLC OH701

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other