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

Model Number	ESS305
Medical Device Problem Codes	Use of Device Problem (1670); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Genital Bleeding (4507); Pelvic Pain (4865)
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer case number: (b)(4).Perforations "[perforation of organ]".Bleeding "[genital bleeding]".Severe pain "[pelvic pain female]".Difficulties with insertion or removal "[device insertion difficult]".Difficulties with insertion or removal "[device difficult to remove]".Case narrative: this spontaneous case was reported by a consumer and describes the occurrence of perforation ("perforations"), genital haemorrhage ("bleeding") and pelvic pain ("severe pain") in a female patient who had essure inserted for female sterilisation.Product or product use issues identified: device insertion difficult ("difficulties with insertion or removal") and device difficult to remove ("difficulties with insertion or removal").There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient had essure inserted.On unknown dates she experienced perforation (seriousness criteria hospitalisation and medically important), genital haemorrhage (seriousness criterion hospitalisation) and pelvic pain (seriousness criterion hospitalisation).At the time of the report, all of the events were resolving.The reporter considered genital haemorrhage, pelvic pain and perforation to be related to essure administration.Further company follow-up with the consumer is not possible.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) perforations "[perforation of organ]", bleeding "[genital bleeding]", severe pain "[pelvic pain female]", difficulties with insertion or removal "[device insertion difficult]", difficulties with insertion or removal "[device difficult to remove]".Case narrative: this spontaneous case was reported by a consumer and describes the occurrence of perforation ("perforations"), genital haemorrhage ("bleeding") and pelvic pain ("severe pain") in a female patient who had essure inserted for female sterilisation.Product or product use issues identified: device insertion difficult ("difficulties with insertion or removal") and device difficult to remove ("difficulties with insertion or removal").There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient had essure inserted.On unknown dates she experienced perforation (seriousness criteria hospitalisation and medically important), genital haemorrhage (seriousness criterion hospitalisation) and pelvic pain (seriousness criterion hospitalisation).At the time of the report, all of the events were resolving.The reporter considered genital haemorrhage, pelvic pain and perforation to be related to essure administration.The reporter commented: essure has been taken off the market but remains in the bodies of thousands of brazilian women, causing harm.The permanent contraceptive device was banned by national health agencyagency following reports of serious complications.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 reason for the reported complaint.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: 11-sep-2026: quality safety evaluation of product technical complaint.Further company follow-up with the consumer is not possible.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: 50609704
• Report Number: 2951250-2026-00280
• Device Sequence Number: 10732909
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: 10888853003051
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: P020014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2026

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: Not provided
• Supplement Date Received by Manufacturer: 09/05/2026; 09/11/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/07/2026; 09/14/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Female