BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VORTEK SINGLE LOOP URETERAL STENT

    MDR report key: 16539769 · Received March 14, 2023

    Report

    Report Number
    9610711-2023-00038
    Event Type
    Injury
    Date Received
    March 14, 2023
    Report Date
    April 25, 2023
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAD
    PMA / PMN Number
    K201436
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINT DESCRIPTION, THE INCRIMINATED SAMPLE IS NOT AVAILABLE, BUT WE HAVE THE LOT NUMBER. AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND FOUND NONE REGARDING THE LOT NUMBER 1001079. THE SAMPLE OF PRODUCT REFERENCE (B)(4), LOT NUMBER 10010719 WAS MANUFACTURED IN FEBRUARY 2010. THE EXPIRY DATE IS JANUARY 2015. CHECKING THE QUALITY DATABASES DID NOT REVEAL ANY ANOMALY IN RELATION TO THE DESCRIBED DEFECT. DOCUMENTARY INVESTIGATION REVEALED THAT PRODUCT WAS EXPIRY SINCE JANUARY 2015. SO, THIS PRODUCT SHOULD NOT HAVE BEEN USED AFTER THIS DATE. RMF IDENTIFICATION WAS DONE BASED ON CRIQ215 RISK NO:10300 PRODUCT PERFORMANCE DOES NOT MEET SPECIFICATIONS.

    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.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED ADDITIONAL SURGERY DUE TO PAIN. THE PATIENT HAD ABDOMINAL PAIN FROM THE DEVICE STIFFNESS. THE BAG REPLACEMENT CAUSED HEMATURIA AND PRODUCED DEPOSITS INSIDE THE DEVICE LUMEN SO THE URINE DID NOT FLOW WELL. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934343 VORTEK SINGLE LOOP URETERAL STENT URETERAL STENT FAD COLOPLAST A/S ACA1081002 10010719

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention