BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BANDER URETERAL DIVERSION STENT SET

    MDR report key: 22792197 · Received August 13, 2025

    Report

    Report Number
    1820334-2025-00978
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 23, 2025
    Report Date
    August 13, 2025
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002575813
    PMA / PMN Number
    K181971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D2A: ADDITIONAL COMMON DEVICE NAME: LJE CATHETER, NEPHROSTOMY. D2B: ADDITIONAL PROCODE: LJE. E1: INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). H3: DEVICE EVALUATED BY MFG? DEVICE ANTICIPATED BUT NOT YET RETURNED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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

    IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND WITHIN THE PACKAGING OF A BANDER URETERAL DIVERSION STENT SET. WHEN THE DISTRIBUTOR WAS PERFORMING AN INCOMING INSPECTION OF THE COMPLAINT DEVICE, A HAIR LIKE FIBER WAS DISCOVERED WITHIN THE PACKAGING. NO PATIENT CONTACT WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813777 BANDER URETERAL DIVERSION STENT SET FAD STENT, URETERAL FAD COOK INC G57581 16623335 00827002575813

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown