BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE STENT SET

    MDR report key: 9774060 · Received March 2, 2020

    Report

    Report Number
    3005580113-2020-00269
    Event Type
    Injury
    Date Received
    March 2, 2020
    Date of Event
    February 3, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    UDI-DI
    10827002341118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE COMMON NAME: FAD STENT, URETERAL. PRODUCT CODE: FAD.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORTER "UPON RETRIEVAL, THE STENT BROKE." IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED BY PULLING ON STENT UNTIL IT FINALLY CAME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238049 RESONANCE STENT SET FAD COOK IRELAND LTD G34111 C1382287 10827002341118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention