BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOF-FLEX MULTI-LENGTH URETERAL STENT SET

    MDR report key: 20521559 · Received October 24, 2024

    Report

    Report Number
    1820334-2024-01395
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Report Date
    October 21, 2025
    Manufacturer
    COOK INC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    . E1: CUSTOMER (PERSON) ADDRESS = (B)(6). G4: PMA/510(K) NUMBER = K180053. 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 THE TETHER 'STRINGS' DETACHED FROM A 'SOF-FLEX MULTI-LENGTH URETERAL STENT' DURING ATTEMPTED REMOVAL. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424568 SOF-FLEX MULTI-LENGTH URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G15696 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown