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 Problem Autoimmune Disorder (1732)

Event Date 01/01/2018

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ((b)(6), reference number: (b)(4)) on 19-apr-2021.This spontaneous case was reported by a consumer and describes the occurrence of sarcoidosis ('sarcoidosis') in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.In 2013, the patient experienced migraine ("migraine").In 2018, the patient experienced sarcoidosis (seriousness criterion medically significant) with musculoskeletal pain and fatigue.Essure treatment was not changed.At the time of the report, the sarcoidosis was resolving and the migraine outcome was unknown.The reporter provided no causality assessment for migraine and sarcoidosis with essure.The reporter commented: on (b)(6) 2021 i had an appointment with the gynaecologist, on (b)(6) 2021 she had the follow-up ultrasound and she was awaiting a date to have them essure removed.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 case was initially received via regulatory authority (ansm, reference number: (b)(4)) on 19-apr-2021.The most recent information was received on 28-apr-2021.This spontaneous case was reported by a consumer and describes the occurrence of sarcoidosis ('sarcoidosis') in a 35-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.In 2013, the patient experienced migraine ("migraine").In 2018, the patient experienced sarcoidosis (seriousness criterion medically significant) with musculoskeletal pain and fatigue.Essure treatment was not changed.At the time of the report, the sarcoidosis was resolving and the migraine outcome was unknown.The reporter provided no causality assessment for migraine and sarcoidosis with essure.The reporter commented: on (b)(6) 2021 had an appointment with the gynaecologist, on (b)(6) 2021 she had the follow-up ultrasound and she was awaiting a date to have them essure removed.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 28-apr-2021: 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
• MDR Report Key: 11708102
• MDR Text Key: 262162939
• Report Number: 2951250-2021-01294
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

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
• Device Operator: Health Professional
• Device Model Number: ESS305
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR