BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JJ SI O/O DIR FIX CO CH06 26

    MDR report key: 7566435 · Received June 4, 2018

    Report

    Report Number
    9610711-2018-00008
    Event Type
    Injury
    Date Received
    June 4, 2018
    Report Date
    July 26, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAD
    PMA / PMN Number
    K013921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO OTHER COMPLAINTS FOUND FOR THIS LOT NUMBER. CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. UNFORTUNATELY NO SAMPLE IS AVAILABLE FROM THE CUSTOMER AND WE CANNOT GO FURTHER THAN THE DOCUMENTARY INVESTIGATION, WHICH DIDN'T REVEAL ANY ANOMALY RECORDED DURING PRODUCTION. ACCORDING TO THE IFU : PRECAUTION: THE CHOICE OF THE CHARACTERISTICS OF THE STENT IS UNDER THE RESPONSIBILITY OF THE PHYSICIAN. CONCLUSION: THE USE OF DOUBLE LOOP URETERAL STENT HAS BECOME A STANDARD PART OF UROLOGICAL PRACTICE. FOR THE URETERAL STENTS MADE OF SILICONE, IT IS IMPORTANT THAT THE ADEQUATE SIZE THAT FITS THE PATIENT BE SELECTED TO AVOID ANTEGRADE MIGRATION TOWARDS THE BLADDER. THIS TYPE OF MEDICAL DEVICE MUST ONLY BE USED BY TRAINED AND EXPERIENCED PROFESSIONALS. BASED ON THE ABOVE THIS COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, DISTAL TIP OF THE STENT FELL OFF FROM KIDNEY TO URETHRA. THIS ISSUE FOUND AS THE PATIENT HAD FEVER AFTER ESWL. THROUGH DETAIL EXAM, PYELONEPHRITIS AND HYDROPHROSIS WERE ALSO DIAGNOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408297 JJ SI O/O DIR FIX CO CH06 26 URETERAL STENT FAD COLOPLAST A/S AJ42641002 5675572

    Patients

    Seq Age Sex Outcome Treatment
    1 Other