BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE SHEATH

    MDR report key: 21447926 · Received February 24, 2025

    Report

    Report Number
    MW5166738
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 19, 2025
    Report Date
    February 19, 2025
    Manufacturer
    CONTURA INTERNATIONAL A/S
    Product Code
    LNM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BULKAMID SHEATH CRACKED DURING CASE. A NEW ONE WAS OBTAINED. SHEATH WAS INSIDE THE PATIENT BUT FULLY REMOVED. A CYSTOSCOPIC EXAMINATION WAS PERFORMED TO ENSURE THERE WERE NOT ANY PARTICLES LEFT BEHIND IN BLADDER OR BLADDER NECK. PROCEEDED WITH CASE - NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472178 ROTATABLE SHEATH AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM CONTURA INTERNATIONAL A/S 101456

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female