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

Model Number	ESS305
Medical Device Problem Code	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 will be 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 will be 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.In 2008, 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 is scheduled on (b)(6) 2026,).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: at the end of 2008, i underwent a medical procedure known as the ¿essure sterilization method¿ after this procedure, various physical symptoms have developed.On (b)(6) 2026, a follow-up procedure will be performed, and the foreign-body material will be removed.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.
Additional Manufacturer Narrative
Bayer case number: (b)(4) foreign-body material will be 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 will be 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.In 2008, 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 is scheduled on (b)(6) 2026,).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: at the end of 2008, i underwent a medical procedure known as the ¿essure sterilization method¿ after this procedure, various physical symptoms have developed.On (b)(6) 2026, a follow-up procedure will be performed, and the foreign-body material will be removed.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed, and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 17-sep-2026: quality safety evaluation of product technical complaint.Case comments: based on the available information, a review of our complaint records and other relevant data was 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: 50766712
• Report Number: 2951250-2026-00285
• Device Sequence Number: 9667925
• 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: 2008
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 09/10/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 09/18/2026
• 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