BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE STENT SET

    MDR report key: 9764548 · Received February 27, 2020

    Report

    Report Number
    3005580113-2020-00263
    Event Type
    Injury
    Date Received
    February 27, 2020
    Date of Event
    October 8, 2019
    Report Date
    February 27, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    UDI-DI
    10827002341118
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE: FAD STENT, URETERAL.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORTER, THE PHYSICIAN ATTEMPTED A BI-LATERAL STENT EXCHANGE HOWEVER WAS UNABLE TO RETRIEVE THE STENTS. IT WAS LATER REPORTED DURING THE PCNL (PERCUTANEOUS NEPHROLITHOTOMY), A RIGID CYSTOSCOPE WITH FLEXIBLE GRASPER WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225007 RESONANCE STENT SET FAD COOK IRELAND LTD G34111 C1484934 10827002341118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention