BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERVENTIONAL CATHETER

    MDR report key: 15149750 · Received August 2, 2022

    Report

    Report Number
    2125050-2022-00748
    Event Type
    Malfunction
    Date Received
    August 2, 2022
    Date of Event
    June 15, 2022
    Report Date
    October 21, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    PMA / PMN Number
    K201007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BRAND NAME: IN-KA URETERAL BALLOON DILATATION CATHETER. 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 SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE RETURNED DEVICE REVEALED A VISIBLE HOLE, AND THE BALLOON WOULD NOT INFLATE. THE CAUSE OF THE BURST COULD NOT BE CONFIRMED. CORRECTION: THE CFN/FEI & MANUFACTURING SITE WERE PREVIOUSLY REPORTED AS CFN/FEI #2125050, MANUFACTURING SITE COLOPLAST MANUFACTURING US, LLC, 1601 WEST RIVER ROAD NORTH, MINNEAPOLIS, MN. THE CFN/FEI IS CORRECTED TO #9610711 AND THE MANUFACTURING SITE IS CORRECTED TO COLOPLAST A/S MANUFACTURING, 9 AVENUE EDMOND ROSTAND, SARLAT-LA-CANEDA, FRANCE, 24206.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON BROKE DURING THE INFLATION. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704579 INTERVENTIONAL CATHETER DILATOR, CATHETER, URETERAL EZL COLOPLAST A/S BD40461002 7794841

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other