BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DILAPAN-S

    MDR report key: 21558345 · Received March 10, 2025

    Report

    Report Number
    3003994796-2025-00002
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    December 23, 2024
    Report Date
    March 25, 2025
    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
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT INDICATED FOR INDUCTION OF LABOUR (IOL) WITH 4 RODS OF DILAPAN-S INSERTED ((B)(6)/2024). DURING DILATION THE PATIENT NOTICED THAT THE RODS FELL OUT INTO THE TOILET, THIS WAS INSPECTED BY MIDWIFE WHO WAS ABLE TO SEE ONLY 3 RODS. THE PATIENT WAS DILATED ENOUGH FOR AN ARTIFICIAL RUPTURE OF MEMBRANES (ARM) AS A NEXT STAGE OF THE INDUCTION PROCESS. DURING IOL PATIENT HAD SIGNS OF INFECTION AND WAS TREATED WITH ANTIBIOTICS. FETUS ALSO SHOWED SIGNS THAT THERE WAS INFECTION (CHORIOAMNIONITIS). DECISION MADE FOR EMERGENCY LOWER SEGMENT CAESAREAN SECTION (LSCS) DUE TO THIS. THE CAUSE OF INFECTION (CHORIOAMNIONITIS) IS NOT KNOWN AND POTENTIAL CONNECTION TO THE USE OF DILAPAN-S CANNOT BE EXCLUDED. THE UTERINE AND PELVIC CAVITIES WERE THOROUGHLY CHECKED IN THEATRE (DURING LSCS), AND THE MISSING DILATOR WAS NOT FOUND TO BE IN SITU. NO OTHER EXAMINATION PERFORMED BASED ON THE ASSESSMENT OF THE RESPONSIBLE HEALTH CARE PROFESSIONAL (HCP). ONE MONTH LATER ((B)(6)2025) WHEN REVIEWING THE CASE BY HOSPITAL'S STUFF IN THE INTERNAL DATABASE OF CASES THAT WERE SOMEHOW ESCALATED TO FOR SAFETY OVERSIGHT, IT WAS DECIDED TO SEND THE PATIENT FOR ULTRASOUND SCAN (USS) 4 WEEKS POST DELIVERY. DURING EXAMINATION THE HCP WAS UNABLE TO EXCLUDE MISSING ROD NOT IN A COLLECTION SEEN ON USS THEREFORE MRI CONSIDERED. THE DECISION TO PERFORM THE MRI WAS DONE ((B)(6)2025). DURING COMMUNICATION ON (B)(6)2025 IT WAS CONFIRMED WITH THE MRI EXAMINATION THAT THE PATIENT IS CLEAR AND NO ROD WAS LEFT IN SITU. THE REASON FOR REPORTING IS THAT PATIENT REQUIRED TREATMENT FOR INFECTION (CHORIOAMNIONITIS). THE CAUSALITY WITH USE OF DILAPAN-S HAS NOT BEEN ESTABLISHED. HOWEVER, IT CANNOT BE EXCLUDED. THE SECOND ASPECT OF THIS EVENT (THE MISSING ROD) IS NOT CONSIDERED A REPORTABLE EVENT. IT WAS CONFIRMED THAT THE PATIENT IS CLEAR AND NO ROD WAS LEFT IN SITU AS WAS ASSUMED IN THE INITIAL REPORT WHEN THE HOSPITAL DID NOT REPORT ANY PATIENT'S COMPLICATIONS, AND THE DILATOR WAS NOT FOUND DURING LSCS CAVITY CHECK.

    Description of Event or Problem · 0

    PATIENT INDICATED FOR INDUCTION OF LABOUR (IOL) WITH 4 RODS OF DILAPAN-S INSERTED ((B)(6)2024). DURING DILATION THE PATIENT NOTICED THAT THE RODS FELL OUT INTO THE TOILET, THIS WAS INSPECTED BY MIDWIFE WHO WAS ABLE TO SEE ONLY 3 RODS. THE PATIENT WAS DILATED ENOUGH FOR AN ARTIFICIAL RUPTURE OF MEMBRANES (ARM) AS A NEXT STAGE OF THE INDUCTION PROCESS. DURING IOL PATIENT HAD SIGNS OF INFECTION AND WAS TREATED WITH ANTIBIOTICS. FETUS ALSO SHOWED SIGNS THAT THERE WAS INFECTION (CHORIOAMNIONITIS). DECISION MADE FOR EMERGENCY LOWER SEGMENT CAESAREAN SECTION (LSCS) DUE TO THIS. THE CAUSE OF INFECTION (CHORIOAMNIONITIS) IS NOT KNOWN AND POTENTIAL CONNECTION TO THE USE OF DILAPAN-S CANNOT BE EXCLUDED. THE UTERINE AND PELVIC CAVITIES WERE THOROUGHLY CHECKED IN THEATRE (DURING LSCS), AND THE MISSING DILATOR WAS NOT FOUND TO BE IN SITU. NO OTHER EXAMINATION PERFORMED BASED ON THE ASSESSMENT OF THE RESPONSIBLE HEALTH CARE PROFESSIONAL (HCP). ONE MONTH LATER ((B)(6)2025) WHEN REVIEWING THE CASE BY HOSPITAL'S STUFF IN THE INTERNAL DATABASE OF CASES THAT WERE SOMEHOW ESCALATED TO FOR SAFETY OVERSIGHT, IT WAS DECIDED TO SEND THE PATIENT FOR ULTRASOUND SCAN (USS) 4 WEEKS POST DELIVERY. DURING EXAMINATION THE HCP WAS UNABLE TO EXCLUDE MISSING ROD NOT IN A COLLECTION SEEN ON USS THEREFORE MRI CONSIDERED. THE DECISION TO PERFORM THE MRI WAS DONE ((B)(6)2025). IT IS NECESSARY TO OBTAIN MORE INFORMATION FROM THE HOSPITAL. THE REASON FOR REPORTING IS THAT PATIENT REQUIRED TREATMENT FOR INFECTION (CHORIOAMNIONITIS). THE CAUSALITY WITH USE OF DILAPAN-S HAS NOT BEEN ESTABLISHED. HOWEVER, IT CANNOT BE EXCLUDED. THE SECOND ASPECT OF THIS EVENT (THE MISSING ROD) IS STILL UNDER REVIEW AND ASSESSMENT WILL FOLLOW IN THE FOLLOW-UP REPORT. GIVEN THAT THE HOSPITAL DID NOT REPORT ANY PATIENT'S COMPLICATIONS, AND THE DILATOR WAS NOT FOUND DURING LSCS CAVITY CHECK, IT IS VERY UNLIKELY THAT THE MISSING ROD IS STILL IN SITU. HOWEVER, USS AND MRI ARE PERFORMED TO RULE OUT ANY SUSPICION. WE ARE IN CONTACT WITH THE LOCAL DISTRIBUTOR AND THE FACILITY TO OBTAIN MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090325 DILAPAN-S DILAPAN-S PKN MEDICEM TECHNOLOGY S.R.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other