BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSA FIRM URETERAL STENT SET

    MDR report key: 8700707 · Received June 14, 2019

    Report

    Report Number
    1820334-2019-01454
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 13, 2019
    Report Date
    July 17, 2019
    Manufacturer
    COOK INC
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B1: THERE WAS NO ADVERSE EVENT OR REPORTABLE PRODUCT MALFUNCTION. H1: THERE WAS NO SERIOUS INJURY TO THE PATIENT. CLARIFIED INFORMATION REVEALED THAT THE PATIENT DID NOT REQUIRE PERCUTANEOUS REMOVAL OF THE DEVICE. H6: DEVICE CODE: APPROPRIATE CODE NOT AVAILABLE: THERE WAS NO ADVERSE EVENT. THERE WAS NO REPORTABLE DEVICE MALFUNCTION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. BASED ON ADDITIONAL INFORMATION RECEIVED, THERE WAS NO SERIOUS INJURY TO THE PATIENT AND NO REPORTABLE PRODUCT MALFUNCTION, THEREFORE A FOLLOW UP REPORT WILL NOT BE SUBMITTED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: THE DEVICE WAS REMOVED TRANSURETHRALLY THROUGH A URETEROSCOPE UNDER GENERAL ANESTHESIA, NOT PERCUTANEOUSLY WITH A LAPAROSCOPE AS ORIGINALLY REPORTED. THE DEVICE WILL NOT BE RETURNED, IT WAS DISCARDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    PMA/510(K): K161236. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, A UNIVERSA FIRM URETERAL STENT SET WAS DIFFICULT TO REMOVE FROM A (B)(6) MALE PATIENT WITH A HISTORY OF MULTIPLE KIDNEY STONES, URINARY TRACT INFECTION, LEFT UPPER URETERAL CALCULI, AND MODERATE FLUID ACCUMULATION IN THE LEFT KIDNEY. THE ENCRUSTED LEFT URETERAL STENT WAS REMOVED PERCUTANEOUSLY WITH A LAPAROSCOPE UNDER GENERAL ANESTHESIA. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494264 UNIVERSA FIRM URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other