BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DILAPAN-S

    MDR report key: 21489460 · Received February 28, 2025

    Report

    Report Number
    3003994796-2025-00001
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    January 8, 2025
    Report Date
    February 28, 2025
    Manufacturer
    MEDICEM TECHNOLOGY S.R.O.
    Product Code
    PKN
    PMA / PMN Number
    K143447
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE PATIENT INDICATED FOR A DILATION PROCEDURE FOLLOWING A STILLBIRTH. TWO RODS WERE INSERTED IN THE EVENING. DURING REMOVAL THE NEXT DAY MORNING (AFTER 14,5 HOURS) ONE OF THE ROD WAS REMOVED SUCCESSFULLY, THE SECOND ROD WAS TORN - A FRAGMENT REMAINED IN THE PATIENT. AN ECHOGRAM SHOWED THAT THE FRAGMENT HAS ENTERED THE UTERUS. BASED ON CLINICAL JUDGEMENT THE HEALTHCARE PROFESSIONAL (HCP) DECIDED TO KEEP THE FRAGMENT IN SITU AND CONTINUE WITH DILATION PROCEDURE. THE HCP CONCLUDED THAT THE FRAGMENT WOULD LEAVE THE BODY SPONTANEOUSLY WITH THE FOETUS DURING STILLBIRTH. THEREFORE, NEXT ROUND OF RODS (7 OR 8) WAS INSERTED TO DILATE THE CERVIX. THE NEXT MORNING, ALL RODS WERE REMOVED AND THE FOETUS WAS DELIVERED. IT WAS CONFIRMED THAT THE RETAINED FRAGMENT WAS EXPELLED DURING THE STILLBIRTH. NO HARM WAS CAUSED TO THE PATIENT. ALTHOUGH THE PROCEDURE WAS PROLONGED DUE TO THE LOCATION OF THE RETAINED FRAGMENT, IT DID NOT AFFECT THE PATIENT'S CONDITION (NOT CLINICALLY SIGNIFICANT). NO QUALITATIVE ISSUE BASED ON BATCH REVIEW. DEVICE ENTRAPMENT AND FRAGMENTATION ARE KNOWN COMPLICATIONS THAT MAY OCCUR DURING A DILATION PROCEDURE. THEIR LIST IS EMPHASIZED IN THE INSTRUCTIONS FOR USE SUPPLIED WITH THE DEVICE, TOGETHER WITH THE RECOMMENDED STEPS HOW TO PROCEED IN CASE OF THEIR OCCURRENCE AND WARNING THAT THE DEVICE (OR ITS FRAGMENTS) SHOULD NOT BE LEFT IN PLACE FOR MORE THAN 24 HOURS. WE SUSPECT VERY UNFAVOURABLE CERVIX (TOO TIGHT) ALLOWING INSERTION OF ONLY 2 RODS IN THE FIRST ROUND OF DILATION, THUS INCREASING THE LIKELIHOOD OF ROD ENTRAPMENT AND CONSEQUENT FRAGMENTATION. THE FRAGMENT WAS SUCCESSFULLY REMOVED DURING STILLBIRTH. THE FRAGMENT REMAINED IN THE BODY > 24H (APPROX. 1,5 DAYS) WAS ASSESSED BY THE HCP AND DECIDED TO BE EXPELLED DURING A STILLBIRTH. THIS DECISION WAS MADE AS PROFESSIONAL CLINICAL JUDGEMENT CONSIDERING THE BENEFIT/RISK RATIO HAVING THE PATIENT UNDER SUPERVISION (TO ELIMINATE THE PROBABILITY OF POTENTIAL INFECTION). THE PATIENT WAS UNDER SUPERVISION, IT WAS A DELIBERATE DECISION AND A CONTROLLED PROCESS. DUE TO THE FACT, THAT THERE WERE NO CONCERNS ABOUT DETERIORATION IN STATE OF HEALTH OF THE PATIENT, WE CONSIDER THIS INCIDENT TO BE "NO APPARENT ADVERSE EVENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572254 DILAPAN-S Dilator, cervical, synthetic, osmotic PKN MEDICEM TECHNOLOGY S.R.O. DS270922465

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other