MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ("the foreign-body material was 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) 2016, 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: various physical symptoms developed after this procedure.I have since had follow-up treatments and the foreign-body material was removed.As a result of the symptoms, i am hindered in my normal daily functioning and i suffer damages.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.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ("the foreign-body material was removed") in a female patient who had essure inserted for permanent contraceptive tubal implant.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2016, 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: various physical symptoms developed after this procedure.I have since had follow-up treatments and the foreign-body material was removed.As a result of the symptoms, i am hindered in my normal daily functioning and i suffer damages.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: 26-mar-2024: quality safety evaluation of ptc.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.

• Brand Name: ESSURE
• Type of Device: 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, NJ 07981
• MDR Report Key: 18966822
• MDR Text Key: 338434666
• Report Number: 2951250-2024-00205
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2024
• 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): Required Intervention
• Patient Sex: Female