BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DILAPAN-S

    MDR report key: 16002704 · Received December 19, 2022

    Report

    Report Number
    3003994796-2022-00002
    Event Type
    Injury
    Date Received
    December 19, 2022
    Date of Event
    December 14, 2022
    Report Date
    December 19, 2022
    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

    Description of Event or Problem · 0

    THE PATIENT INDICATED FOR IOL (INDUCTION OF LABOUR) USING DILAPAN-S. THE PATIENT - GRAVIDA 2, PARITY 1, 37+6 WEEKS GESTATION, PREVIOUS INSTRUMENTAL DELIVERY WITH FORCEPS, INDUCED FOR IOL FOR PRE-ECLAMPSIA - ON 200MG LABETALOL BD, RAISED BMI 39. 4 RODS WERE INSERTED ON (B)(6)2022 AS PART OF INDUCTION PROCESS, THE RODS WERE INSERTED FOR 15 HOURS. ON (B)(6) 2022 THE HCP (HEALTH CARE PROFESSIONAL) ATTEMPTED TO REMOVE THE RODS ON VAGINAL EXAMINATION BUT THEY WERE NOT ABLE TO LOCATE THE RODS IN CERVIX OR VAGINA. BOTH A SPECULUM AND DIGITAL EXAMINATION WERE UNABLE TO LOCATE ANY DILATORS IN SITU. TRANSABDOMINAL AND A TRANSVAGINAL USS WERE PERFORMED AND THEY WERE UNABLE TO LOCATE THE RODS WITH EITHER SCAN (POSSIBLE RETRACTION INTO THE UTERUS IS MENTIONED). FURTHER ATTEMPT TO REMOVE RODS VIA SPECULUM AND VAGINAL EXAMINATION WAS UNSUCESSFUL. RODS REMAINED IN SITU AND THE PATIENT WAS TRANSFERRED TO DELIVERY SUITE FOR MONITORING AND CONTINUATION OF INDUCTION PROCEDURE. THE PATIENT WAS GIVEN THE OPTION OF CONTINUING HER INDUCTION OR OPTING FOR CS (CAESAREAN SECTION). IT WAS DISCUSSED THAT AS SHE WASN'T IN ESTABLISHED LABOUR, SHE WOULD NEED SECOND STAGE CERVICAL RIPENING TO INDUCE CONTRACTIONS AND THAT THE CONSULTANT WAS UNSURE HOW THE POTENTIAL RETAINED RODS WOULD IMPACT HER AND THE BABY WHEN THE CONTRACTIONS STARTED. THE SAME DAY ON (B)(6) 2022 EVENING THE HCP (AFTER DISCUSSION AND OBTAINING THE PATIENT'S CONSENT) DECIDED TO PERFORM CS INSTEAD OF CONTINUING IN INDUCTION. THE MISSING RODS WERE SUPPOSED TO BE REMOVED DURING CS (AS CONFIRMED WITH THE FACILITY DURING A CONSULTATION). LATER IT WAS CONFIRMED WITH THE MRI SCAN OBTAINED ON (B)(6) 2022 THAT EXCLUDED THE PRESENCE OF THE DILATORS IN SITU. BOTH PATIENT AND THE BABY ARE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701248 DILAPAN-S Dilator, cervical, synthetic, osmotic PKN MEDICEM TECHNOLOGY S.R.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other