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

Model Number 4X55 MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Uterine Perforation (2121)

Event Date 10/31/2021

Event Type  Injury  

Event Description

The patient with ovarian mass on mri was indicated for induction of labour (iol) using dilapan-s.Caesarean section was performed for failed iol.Ovarian mass was removed at the time of section.A perforation of the uterus recorded - suture required.The perforation was close to the mass that they had removed.The facility mentions that the perforation may be caused by dilapan-s, however the pre-existing conditions (ovarian mass and associated predisposition of the uterus to rupture) could contribute or even cause the perforation of the uterus together with the appropriate use of dilapan-s.Available information is inconclusive.No direct causality between the event and use of dilapan-s has already been established, it is necessary to wait for the planned meeting with the facility and clarify the ambiguous information in the case (delayed by hcp overload).The classification of this case as an adverse incident will be re-assessed once the evidence is unambiguous.

Event Description

The patient with ovarian mass on mri was indicated for induction of labour (iol) using dilapan-s.Caesarean section (cs) was performed for failed iol.Ovarian mass was removed at the time of section.The reason for the cs was the failed iol together with the necessity to remove the ovarian mass.During initial assessment a perforation of the uterus was reported to the manufaturer.This information was denied on 16/12/2021 in the investigation report from the facility - no perforation of the uterus occured.The updated report shows that there was internal os injury with bleeding probably caused by handling of inserted rods during their removal.This is anticipated complication associated with use of the device and therefore described in the ifu.The injury required suture however no harm to the patient occured as reported by the facility.Based on new information from the affected healthcare facility (reported on 16/12/2021) the event is classified by the manufacturer as a non-reportable incident.The event did not lead and might not have led to serious deterioration in state of health of the patient - as reported by the facility.

• Brand Name: DILAPAN-S
• Type of Device: HYGROSCOPIC CERVICAL DILATOR
• Manufacturer (Section D): MEDICEM TECHNOLOGY S.R.O.; karlovarska trida 20; kamenne zehrovice, czech republic 27301 ; EZ 27301
• Manufacturer Contact: jan waclav ; karlovarska trida 20; kamenne zehrovice, czech republic 27301 ; EZ 27301
• MDR Report Key: 12914655
• MDR Text Key: 281573941
• Report Number: 3003994796-2021-00002
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4X55 MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2021
• 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): Other
• Patient Sex: Female