MAUDE Adverse Event Report: Bayer Pharma AG ESSURE; Transcervical Contraceptive Tubal Occlusion Device

Model Number	ESS305
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer case number: (b)(4) foreign-body material has been removed "[medical device removal]" case narrative: this spontaneous case was reported by a consumer and describes the occurrence of medical device removal ("foreign-body material has been removed") in a female patient who had essure inserted for female sterilization.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2010, the patient had essure inserted.On unknown date she underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery (to remove essure).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.The reporter commented: after this procedure, various physical symptoms have developed.I have since had follow-up treatments, and the foreign-body material has been removed.As a result of the symptoms, i am hindered in my normal daily functioning, and i suffer damages.Case comments: based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.In case a sample is received, the investigation might lead to destruction of the sample if required to perform a proper analysis.

• Brand Name: ESSURE
• Common Device Name: Transcervical Contraceptive Tubal Occlusion Device
• Manufacturer (Section D): Bayer Pharma AG; müllerstr. 178; berlin 13353 ; GM 13353
• Manufacturer (Section G): Bayer Pharma AG; müllerstr. 178; berlin 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd, p.o. box 915; whippany 07981--091 ; +1(862)404-3698
• MDR Report Key: 50813823
• Report Number: 2951250-2026-00286
• Device Sequence Number: 10218537
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: 10888853003051
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• PMA/510(K) Number: P020014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/18/2026
• Supplement Report FDA Received Date: 09/22/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female