BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE LOOP URETERAL STENT

    MDR report key: 17936620 · Received October 14, 2023

    Report

    Report Number
    9610711-2023-00221
    Event Type
    Malfunction
    Date Received
    October 14, 2023
    Report Date
    July 29, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAD
    PMA / PMN Number
    K201436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN¿T FIND OTHER COMPLAINT ON THE LOT N°9191002. CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. WE INFORMED OUR HUNGARIAN SITE TO INVESTIGATE WITH THE RECIEVED SAMPLE. THE INVESTIAGTION CONCLUDED:"THIS ITEM IS PRODUCED ON THE 1SS1 MANUAL CELL. DURING PRODUCTION WE RECEIVE THE SA4205 BAG WITH 3 SIDE OF IT ALREADY SEALED. WE PACK EVERY ACCESSORY IN THIS PACKAGE AND SEAL THE LAST SIDE MANUALLY WITH A MANUAL WELDER. FROM THE SAMPLE IT IS CLEAR THAT THE WELDING OF THE 4TH SIDE WAS NOT DONE. THIS IS AN OPERATOR MISTAKE. DURING OUR YEARLY RETRAINING I RETRAINED EVERY OPERATOR ABOUT THIS FAILURE. "

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO UNSEALED PACKAGING. THE PRIMARY PACKAGING ENVELOPE WAS OPEN AND NOT PROPERLY SEALED. THE DEVICE WAS NO LONGER STERILE AND COULD NOT BE USED.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO UNSEALED PACKAGING. THE PRIMARY PACKAGING ENVELOPE WAS OPEN AND NOT PROPERLY SEALED. THE DEVICE WAS NO LONGER STERILE AND COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969050 SINGLE LOOP URETERAL STENT POLYMERIC URETERAL STENT FAD COLOPLAST A/S 9191002_ACA1061002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown