BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACE URETERAL ACCESS SHEATH

    MDR report key: 17376075 · Received July 24, 2023

    Report

    Report Number
    9610711-2023-00147
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Report Date
    January 9, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FED
    PMA / PMN Number
    K123675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE QUALITY DATABASE REVEALED NO ANOMALY IN RELATION WITH THE DESCRIBED DEFECT. NO OTHER COMPLAINT WAS FOUND REGARDING THE LOT NUMBER 8980719. ONE USED PACKAGING RECEIVED. THIS ONE WAS EMPTY AND OPENED WITH A SCAR OBJECT AT ONE EXTREMITY JUSTE BEFORE THE SEALING. PACKAGING WAS CORRECTLY SEALED AT OUR MANUFACTURING PLANT. NO ROOT CAUSE WAS DEFINED ABOUT THIS ISSUE.

    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 THE AVAILABLE INFORMATION, THE INNER PACKAGE OF THE DIALATOR WAS CUT NEAR SEALING.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THE INNER PACKAGING OF THIS DEVICE WAS NOT SEALED. THE INNER PACKAGE WAS CUT NEAR THE SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749383 RETRACE URETERAL ACCESS SHEATH URETERAL SHEATH FED COLOPLAST A/S 8980719_ACXD121002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown