BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DILAPAN-S

    MDR report key: 12914655 · Received December 2, 2021

    Report

    Report Number
    3003994796-2021-00002
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    October 31, 2021
    Report Date
    December 2, 2021
    Manufacturer
    MEDICEM TECHNOLOGY S.R.O.
    Product Code
    PKN
    PMA / PMN Number
    K143447
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WITH OVARIAN MASS ON MRI WAS INDICATED FOR INDUCTION OF LABOUR (IOL) USING DILAPAN-S. CAESAREAN SECTION WAS PERFORMED FOR FAILED IOL. OVARIAN MASS WAS REMOVED AT THE TIME OF SECTION. A PERFORATION OF THE UTERUS RECORDED - SUTURE REQUIRED. THE PERFORATION WAS CLOSE TO THE MASS THAT THEY HAD REMOVED. THE FACILITY MENTIONS THAT THE PERFORATION MAY BE CAUSED BY DILAPAN-S, HOWEVER THE PRE-EXISTING CONDITIONS (OVARIAN MASS AND ASSOCIATED PREDISPOSITION OF THE UTERUS TO RUPTURE) COULD CONTRIBUTE OR EVEN CAUSE THE PERFORATION OF THE UTERUS TOGETHER WITH THE APPROPRIATE USE OF DILAPAN-S. AVAILABLE INFORMATION IS INCONCLUSIVE. NO DIRECT CAUSALITY BETWEEN THE EVENT AND USE OF DILAPAN-S HAS ALREADY BEEN ESTABLISHED, IT IS NECESSARY TO WAIT FOR THE PLANNED MEETING WITH THE FACILITY AND CLARIFY THE AMBIGUOUS INFORMATION IN THE CASE (DELAYED BY HCP OVERLOAD). THE CLASSIFICATION OF THIS CASE AS AN ADVERSE INCIDENT WILL BE RE-ASSESSED ONCE THE EVIDENCE IS UNAMBIGUOUS.

    Description of Event or Problem · 0

    THE PATIENT WITH OVARIAN MASS ON MRI WAS INDICATED FOR INDUCTION OF LABOUR (IOL) USING DILAPAN-S. CAESAREAN SECTION (CS) WAS PERFORMED FOR FAILED IOL. OVARIAN MASS WAS REMOVED AT THE TIME OF SECTION. THE REASON FOR THE CS WAS THE FAILED IOL TOGETHER WITH THE NECESSITY TO REMOVE THE OVARIAN MASS. DURING INITIAL ASSESSMENT A PERFORATION OF THE UTERUS WAS REPORTED TO THE MANUFATURER. THIS INFORMATION WAS DENIED ON 16/12/2021 IN THE INVESTIGATION REPORT FROM THE FACILITY - NO PERFORATION OF THE UTERUS OCCURED. THE UPDATED REPORT SHOWS THAT THERE WAS INTERNAL OS INJURY WITH BLEEDING PROBABLY CAUSED BY HANDLING OF INSERTED RODS DURING THEIR REMOVAL. THIS IS ANTICIPATED COMPLICATION ASSOCIATED WITH USE OF THE DEVICE AND THEREFORE DESCRIBED IN THE IFU. THE INJURY REQUIRED SUTURE HOWEVER NO HARM TO THE PATIENT OCCURED AS REPORTED BY THE FACILITY. BASED ON NEW INFORMATION FROM THE AFFECTED HEALTHCARE FACILITY (REPORTED ON 16/12/2021) THE EVENT IS CLASSIFIED BY THE MANUFACTURER AS A NON-REPORTABLE INCIDENT. THE EVENT DID NOT LEAD AND MIGHT NOT HAVE LED TO SERIOUS DETERIORATION IN STATE OF HEALTH OF THE PATIENT - AS REPORTED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814533 DILAPAN-S HYGROSCOPIC CERVICAL DILATOR PKN MEDICEM TECHNOLOGY S.R.O. 4X55 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other