BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL CATHETER

    MDR report key: 10062379 · Received May 15, 2020

    Report

    Report Number
    9610711-2020-00014
    Event Type
    Malfunction
    Date Received
    May 15, 2020
    Date of Event
    March 7, 2020
    Report Date
    June 9, 2020
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040130087
    PMA / PMN Number
    K013174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS CREATED TO DOCUMENT THE DEVICE RETURN. THE FINAL ANSWER REMAINS UNCHANGED.

    Additional Manufacturer Narrative · 1

    AFTER RECEIVING THIS COMPLAINT, WE COULD NOT SEARCH FOR OTHER COMPLAINT AS THE LOT NUMBER IS NOT AVAILABLE. WITH THE LOT NUMBER OF THE RED VALVE 6619792, WE FOUND THE PRODUCT INTERMEDIATE IS AA641879 LOT NUMBER 6619792 AND ENTERED IN THE MANUFACTURE IN THE PRODUCT REFERENCE AA64181002 LOT NUMBER 6863149 FOR (B)(4) PIECES WAS MANUFACTURED IN MAY 2019. THE EXPIRY DATE IS MAY 2024. ON MAY 12TH, WE DIDN'T RECEIVE THE ANNOUNCED SAMPLE, BUT THE SILICONE BALLOON ISSUE IS KNOWN. THE SAMPLES ARE DELAYED DUE TO THE COVID-19 SITUATION. THE EXPECTED SAMPLE HAS NOT YET BEEN RECEIVED. UPON RECEIPT, IT WILL BE EXAMINED, THE COMPLAINT WILL BE REOPENED. THE BALLOON BURST ISSUE IS KNOWN AND MONITORED ON A MONTHLY BASIS. POSSIBLE ROOT CAUSE IS A WEAKNESS AREA IN THE SILICONE MATERIAL OF THE BALLOON.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER FELL OFF AFTER 1 DAY INDWELLING. BALLOON BURST WAS FOUND. THE LOT NUMBER OF THE RED VALVE WAS PROVIDED, 6619792.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523820 FOLYSIL CATHETER SILICONE CATHETER EZL COLOPLAST A/S AA64181002 03600040130087

    Patients

    Seq Age Sex Outcome Treatment
    1