MAUDE Adverse Event Report: MEDICEM TECHNOLOGY S.R.O. DILAPAN-S; Dilator, cervical, synthetic, osmotic

Device Problem No Apparent Adverse Event (3189)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/14/2022

Event Type  Injury  

Event Description

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.

• 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: 16002704
• MDR Text Key: 305685354
• Report Number: 3003994796-2022-00002
• Device Sequence Number: 1
• Product Code: PKN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2022
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female