BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DILAPAN-S

    MDR report key: 12472416 · Received September 15, 2021

    Report

    Report Number
    3003994796-2021-00001
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    April 27, 2021
    Report Date
    August 20, 2021
    Manufacturer
    MEDICEM TECHNOLOGY S.R.O.
    Product Code
    PKN
    PMA / PMN Number
    K143447
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR THE PATIENT OR BABY OCCURED. ALL RODS WERE FOUND. THE CS WAS INDICATED FOR OTHER REASONS, THERE IS NO CAUSALITY BETWEEN THE USE OF DILAPAN-S AND CS. INITIALLY, THE CASE WAS NOT CLASSIFIED AS ADVERSE EVENT BASED ON THE AVAILABLE INFORMATION. AS WAS ALSO CONFIRMED WITH THE FACILITY, THE REPORTABILITY CRITERIA WERE NOT MET. THERE WAS NO TANGIBLE HARM TO THE PATIENT OR BABY. THE FACILITY'S DECISION TO REPORT THE CASE WAS MADE WHEN THE SECOND SIMILAR CASE OCCURRED DESPITE THE FACT NO TANGIBLE HARM TO THE PATIENT OR BABY WAS IDENTIFIED AND RECORDED - THE FACILITY'S INITIAL ASSESSMENT IN APRIL WAS "NOT REPORTABLE". THE MANUFACTURER UNDERSTANDS THE FACILITY'S ATTITUDE HOWEVER THERE WAS NO HARM TO THE PATIENT OR BABY AND THE CASE DID NOT LED TO ANY DETERIORATION IN STATE OF THEIR HEALTH. AS SPORADIC EVIDENCE SHOWS SIMILAR CASES WOULD MOST LIKELY RESULT IN SPONTANEOUS EXPULSION OF THE ROD(S) DURING LABOUR PROCESS. TAKING INTO CONSIDERATION THE NEWLY OBTAINED INFORMATION REGARDING ABX ADMINISTRATION, THE MANUFACTURER CANNOT EXCLUDE THAT DILAPAN-S USE MIGHT HAVE LED TO SERIOUS DETERIORATION IN THE STATE OF HEALTH WHICH REQUIRED PROPHYLACTIC ABX ADMINISTRATION. THEREFORE, THE MANUFACTURER DECIDED TO RE-ASSESS THE CASE AS A REPORTABLE INCIDENT. THERE IS NO NEED FOR ANY CAPA. THE RUPTURE OF MEMBRANES AND ROD MIGRATION IS EXPECTED (= DESCRIBED IN THE IFU) AND PROPERLY EVALUATED IN THE MANUFACTURER'S RISK ANALYSIS AS A HYPOTHETICAL HARM TO THE PATIENT HOWEVER REMOTE.

    Description of Event or Problem · 1

    NO SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR THE PATIENT/BABY OCCURED. THE EVENT MIGHT HAVE LED TO SERIOUS DETERIORATION OF HEALTH OF THE PATIENT/BABY. THE EVENT OCCURED IN (B)(6). THIS PATIENT WAS 39 WEEKS PREGNANT. IT WAS HER FIRST ONGOING PREGNANCY. SHE WAS BEING INDUCED FOR RAISED BLOOD PRESSURE. 4 RODS OF DILAPAN-S WERE INSERTED BY A JUNIOR MIDWIFE FOR IOL (INDUCTION OF LABOUR). PATIENT HAD A RUPTURE OF MEMBRANES ON INSERTION OF DILAPAN-S. ALL 4 RODS ENTERED / MIGRATED UP INTO THE UTERUS. THE CAUSALITY OF THE RUPTURE OF MEMBRANES WITH DILAPAN-S INSERTION WAS NOT PROPOSED. UNPLANNED CS (CAESAREAN SECTION) WAS INDICATED DUE TO PATHOLOGICAL CTG. ALL RODS WERE SUCCESSFULLY RETRIEVED DURING CS. DURING THE INITIAL ASSESSMENT ((B)(6) 2021, THAT WAS IMMEDIATELY AFTER RECEIVING THE INITIAL INFORMATION) IT WAS DECIDED THAT THE SERIOUSNESS CRITERIA WERE NOT MET WHICH WAS LATER CONFIRMED WITH THE FACILITY. THE CASE WAS RE-ASSESSED BY THE FACILITY IN (B)(6) BECAUSE ANOTHER SIMILAR CASE (A ROD ENTERING THE UTERUS) OCCURED IN THE FACILITY AND THEY REPORTED BOTH CASES TO THE MHRA. DURING THE MANUFACTURER'S INVESTIGATION (FROM (B)(6) 2021 TO (B)(6) 2021) ADDITIONAL INFORMATION WAS OBTAINED REGARDING INFECTION MARKERS AND ANTIBIOTICS (ABX). THE BABY WAS TREATED FIVE DAYS WITH INTRAVENOUS ABX DUE TO A SUSPECTED INFECTION SECONDARY TO CHORIOAMNIONITIS; THE MOTHER HAD A COURSE OF ORAL ABX. EVENTUALLY, BOTH MOTHER AND BABY WERE WELL AND DISCHARGED HOME. THE ABX WERE ADMINISTERED AS A PREVENTIVE MEASURE TO REDUCE RISK OF INFECTION TO THE PATIENT AND BABY FOLLOWING THE RUPTURE OF MEMBRANES THE MANUFACTURER RE-ASSESSED THE CASE AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375345 DILAPAN-S HYGROSCOPIC CERVICAL DILATOR PKN MEDICEM TECHNOLOGY S.R.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other