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

Model Number ESS305

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

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('essure removal') in an adult female patient who had essure inserted for female sterilisation.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery (essure removed on (b)(6) 2012).Essure was removed on (b)(6) 2012.At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer, and describes the occurrence of medical device removal ('essure removal').In an adult female patient who had essure inserted for female sterilisation.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery (essure removed and oophorectomy).Essure was removed on (b)(6) 2012.At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.The reporter commented: date(s) of removal: (b)(6) 2014 (discrepancy noted).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 13-jul-2020, 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer, and describes the occurrence of pelvic pain ('chronic pelvic pain').In an adult female patient who had essure inserted for female sterilisation.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).The patient was treated with surgery (total laparoscopic hysterectomy, bilateral oophorectomy).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain outcome was unknown.The reporter considered pelvic pain to be related to essure.The reporter commented: date(s) of removal: (b)(6) 2014 (discrepancy noted).Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: pelvic pain.Quality safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-mar-2021, mr received: reporter information added, date of removal updated.Event: medical device removal updated to event, pelvic pain.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
• MDR Report Key: 10216204
• MDR Text Key: 199681665
• Report Number: 2951250-2020-10136
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention