BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 20385678 · Received October 7, 2024

    Report

    Report Number
    1820334-2024-01307
    Event Type
    Injury
    Date Received
    October 7, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 10, 2025
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002148406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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

    AS REPORTED, A 'SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET' WAS PLACED ON (B)(6) 2024 FOR A STENT RE-IMPLANT PROCEDURE AND FRACTURED AT THE PATIENTS HOME ON (B)(6) 2024. THE PATIENT REPORTED TO HAVE PAIN AND PASSED PART OF THE STENT AT HOME; THE PATIENT THEN RETURNED TO THE USER FACILITY FOR REMOVAL OF THE REMAINING STENT FRAGMENTS REMOVED FROM THE URETHRA AND BLADDER. ANOTHER STENT WAS NOT PLACED. THE STENT WAS NOT SET TO BE REMOVED FOR ANOTHER 2 WEE KS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY OTHER ADDITIONAL INTERVENTION OR EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2539099 SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G14840 14830921 00827002148406

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Male Required Intervention