BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DILAPAN-S

    MDR report key: 24051292 · Received January 13, 2026

    Report

    Report Number
    3003994796-2026-00001
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    January 7, 2026
    Report Date
    January 20, 2026
    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

    A PATIENT DIAGNOSED WITH PRE-ECLAMPSIA. DECISION MADE TO PROCEED WITH INDUCTION OF LABOR (IOL): - (B)(6) 2026 AT 16:56: 5 RODS INSERTED FOR IOL, THE PATIENT REQUIRED IV PAIN MANAGEMENT FOR PLACEMENT. - (B)(6) 2026 AT 06:30: RODS WERE REMOVED; ONLY 4 RODS WERE ACCOUNTED FOR. PATIENT WAS UNCOMFORTABLE WITH EXAMINATION. DECISION MADE TO PROCEED WITH IOL. - (B)(6) 2026 AT 09:00: DOCUMENTATION NOTED CERVIX AT 4 CM WITH A PALPABLE ROD POSITIONED TRANSVERSELY ACROSS THE INTERNAL CERVICAL OS. EXACT DELIVERY DATE AND TIME ARE PENDING. A SPONTANEOUS VAGINAL DELIVERY WAS REPORTED WITH SPONTANEOUS PLACENTAL DELIVERY. FOLLOWING DELIVERY AND EVACUATION OF THE UTERUS, A MANUAL UTERINE SWEEP WAS PERFORMED WITH NO ROD NOTED IN THE UTERINE CAVITY, LOWER UTERINE SEGMENT, OR AROUND THE CERVICAL OS. INITIAL ULTRASOUND WAS PERFORMED; FINDINGS WERE INCONCLUSIVE. LATER THE RESPONSIBLE HEALTHCARE PROFESSION (HCP) REPORTED THAT A SECOND ULTRASOUND HAD BEEN COMPLETED WITH THE FOLLOWING FINDING: 3.2 CM LINEAR ECHOGENIC STRUCTURE LOCATED AT THE INTERNAL CERVICAL OS. AN MRI WAS PENDING AT THAT TIME. THE PATIENT REMAINED ON MAGNESIUM SULFATE THERAPY RELATED TO HER PREECLAMPSIA DIAGNOSIS AND CONTINUED TO BE TREATED WITH ANTIBIOTICS. ON (B)(6) 2026 THE 5TH ROD WAS STILL MISSING (> 24 HOURS). ON (B)(6) 2026 THE RESPONSIBLE HCP CONFIRMED THAT THE PATIENT UNDERWENT AN MRI. NOTHING WAS NOTED IN THE UTERUS, LOWER UTERINE SEGMENT, CERVIX OR VAGINAL VAULT. NO FURTHER INTERVENTION WAS DONE AND THE PATIENT WAS DISCHARGED HOME ON POST PARTUM DAY 2. THE MISSING DILATOR WAS MOST LIKELY EXPELLED FROM THE BODY UNNOTICED. A COMPREHENSIVE AND REPEATED SEARCH WAS UNDERTAKEN TO CONFIRM THIS OUTCOME. THE FINAL MRI CONFIRMED THAT NOTHING WAS PRESENT IN THE UTERUS, LOWER UTERINE SEGMENT, CERVIX, OR VAGINAL VAULT. AS NO RETAINED FOREIGN BODY WAS DETECTED, THE INVESTIGATION CONCLUDES THAT THE DILATOR DID NOT REMAIN IN SITU AND WAS SPONTANEOUSLY EXPELLED. BASED ON THE NATURE OF THE EVENT, THE LIKELIHOOD OF A QUALITATIVE DEFECT IN THE DEVICE IS CONSIDERED NEGLIGIBLE. WHILE THE BATCH NUMBER OF THE DEVICE INVOLVED IS NOT KNOWN, THIS DOES NOT IMPACT THE ASSESSMENT, AS NO QUALITATIVE DEFECT IS SUSPECTED.

    Description of Event or Problem · 0

    A PATIENT DIAGNOSED WITH PRE-ECLAMPSIA. DECISION MADE TO PROCEED WITH INDUCTION OF LABOR (IOL): ON (B)(6) 2026 AT 16:56: 5 RODS INSERTED FOR IOL, THE PATIENT REQUIRED IV PAIN MANAGEMENT FOR PLACEMENT. ON (B)(6) 2026 AT 06:30: RODS WERE REMOVED; ONLY 4 RODS WERE ACCOUNTED FOR. PATIENT WAS UNCOMFORTABLE WITH EXAMINATION. DECISION MADE TO PROCEED WITH IOL. ON (B)(6) 2026 AT 09:00: DOCUMENTATION NOTED CERVIX AT 4 CM WITH A PALPABLE ROD POSITIONED TRANSVERSELY ACROSS THE INTERNAL CERVICAL OS. EXACT DELIVERY DATE AND TIME ARE PENDING. A SPONTANEOUS VAGINAL DELIVERY WAS REPORTED WITH SPONTANEOUS PLACENTAL DELIVERY. FOLLOWING DELIVERY AND EVACUATION OF THE UTERUS, A MANUAL UTERINE SWEEP WAS PERFORMED WITH NO ROD NOTED IN THE UTERINE CAVITY, LOWER UTERINE SEGMENT, OR AROUND THE CERVICAL OS. INITIAL ULTRASOUND WAS PERFORMED; FINDINGS WERE INCONCLUSIVE. LATER THE RESPONSIBLE HEALTHCARE PROFESSION (HCP) REPORTED THAT A SECOND ULTRASOUND HAD BEEN COMPLETED WITH THE FOLLOWING FINDING: 3.2 CM LINEAR ECHOGENIC STRUCTURE LOCATED AT THE INTERNAL CERVICAL OS. AN MRI WAS PENDING AT THAT TIME. THE PATIENT REMAINS ON MAGNESIUM SULFATE THERAPY RELATED TO HER PREECLAMPSIA DIAGNOSIS AND CONTINUES TO BE TREATED WITH ANTIBIOTICS. ON (B)(6) 2026 THE 5TH ROD WAS STILL MISSING (> 24 HOURS). SINCE THEN, THERE HAS BEEN NO FURTHER INFORMATION - WE ARE WAITING FOR FEEDBACK FROM THE HOSPITAL AND PROVIDING THE NECESSARY SUPPORT. A FOLLOW-UP REPORT WILL FOLLOW. BASED ON THE NATURE OF THE EVENT, THE LIKELIHOOD OF A QUALITATIVE DEFECT IN THE DEVICE IS CONSIDERED NEGLIGIBLE. WHILE THE BATCH NUMBER OF THE DEVICE INVOLVED IS NOT KNOWN, THIS DOES NOT IMPACT THE ASSESSMENT, AS NO QUALITATIVE DEFECT IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112898 DILAPAN-S DILATOR, CERVICAL, SYNTHETIC, OSMOTIC PKN MEDICEM TECHNOLOGY S.R.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other