MAUDE Adverse Event Report: MEDICEM TECHNOLOGY S.R.O. DILAPAN-S; DILATOR, CERVICAL, SYNTHETIC, OSMOTIC

Device Problem Use of Device Problem (1670)

Patient Problems Pelvic Inflammatory Disease (2000); Foreign Body In Patient (2687)

Event Date 06/12/2019

Event Type  Injury  

Event Description

The patient indicated for top (termination of pregnancy) due to "death foetus" undergone the procedure using the dilator dilapan-s on (b)(6) 2019.During the removal procedure which was performed under critical situation and lack of time (urgent caesarian section that occured in parallel and required presence of the hcp) the breakage of the dilator occured and a 4,5 cm long fragment (as assessed by reporter) remained in the patient's uterus.The responsible hcp (health-care proffesional) tried to remove the fragment, which caused prolongation of the top procedure.The removal was not successful and the patient remained in the hospital.Next day the patient was transported to a different facility to remove the fragment from her body.The second attempt was not successful, infection in the patient's body occured - treated with antibiotics.The patient remained in the hospital till (b)(6) 2019 when she was discharged with the fragment still in the body and continuing treatment with antibiotics.The fragment was reported to leave the body spontaneously the 16th day after the procedure (estimated (b)(6) 2019 as reported by the patient).The patient suffered from persisting complications.The proposed consequence of the infection may be observed obstruction of right-side fallopian tube, causing fertility issues.The case happened in 2019 however the manufacturer was not informed about the event until 1st september 2022 when the first message occurred but contained no information what happened.After continuing effort an official letter with a description of the case from hungarian court was received on 5th december 2022.There is no indication of quality issue, lot is not known.Due to reported non-standard circumstances of dilator(s)' removal the most likely cause is user error.

Event Description

The patient indicated for top (termination of pregnancy) due to "death foetus" undergone the procedure using the dilator dilapan-s on (b)(6) 2019.During the removal procedure which was performed under critical situation and lack of time (urgent caesarian section that occured in parallel and required presence of the hcp) the breakage of the dilator occured and a 4,5 cm long fragment (as assessed by reporter) remained in the patient's uterus.The responsible hcp (health-care proffesional) tried to remove the fragment, which caused prolongation of the top procedure.The removal was not successful and the patient remained in the hospital.Next day the patient was transported to a different facility to remove the fragment from her body.The second attempt was not successful, infection in the patient's body occured - treated with antibiotics.The patient remained in the hospital till (b)(6) 2019 when she was discharged with the fragment still in the body and continuing treatment with antibiotics.The fragment was reported to leave the body spontaneously the 16th day after the procedure (estimated (b)(6) 2019 as reported by the patient).The patient suffered from persisting complications.The proposed consequence of the infection may be observed obstruction of right-side fallopian tube, causing fertility issues.As described in the provided transcript of the hungarian court there exists a hypotetical justification of the issue.Examination of the patient performed a few years after the event (2022) revealed suspect finding of "false route" possible being caused by missplacement of the rod.However there is no tangible evidence of relationship between the reported event and this finding.Due to reported non-standard circumstances of dilator(s)' removal (and suspected incorrect inspertion) the most likely cause is user error.The fragmentation and/or rod displacement is expected (= described in the ifu) and properly evaluated in the manufacturer's risk analysis as a hypothetical harm to the patient however remote.

• Brand Name: DILAPAN-S
• Type of Device: DILATOR, CERVICAL, SYNTHETIC, OSMOTIC
• Manufacturer (Section D): MEDICEM TECHNOLOGY S.R.O.; karlovarska trida 20; kamenne zehrovice, 27301 ; EZ 27301
• Manufacturer Contact: jan waclav ; karlovarska trida 20; kamenne zehrovice, 27301 ; EZ 27301
• MDR Report Key: 15974941
• MDR Text Key: 305418530
• Report Number: 3003994796-2022-00001
• Device Sequence Number: 1
• Product Code: PKN
• Combination Product (y/n): N
• PMA/PMN Number: K143447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Sex: Female