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 Myalgia (2238)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ((b)(6), reference number: (b)(4)) on 24-dec-2021.This spontaneous case was reported by a consumer and describes the occurrence of myalgia ('unexplained muscular pain') in an adult female patient who had essure (batch no.816053) inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: no x-ray or allergy tests performed.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2020, the patient experienced basedow's disease ("basedow's disease (thyroid dysfunction / thyroid problems)").On an unknown date, the patient experienced myalgia (seriousness criterion medically significant), sleep disorder ("sleep disorders"), eye disorder ("eye problems "), fatigue ("fatigue") and disturbance in attention ("loss of concentration") and was found to have weight increased ("weight gain").At the time of the report, the myalgia, sleep disorder, eye disorder, fatigue, disturbance in attention, weight increased and basedow's disease outcome was unknown.The reporter provided no causality assessment for basedow's disease, disturbance in attention, eye disorder, fatigue, myalgia, sleep disorder and weight increased with essure.The reporter commented: numerous health problems over the past 10 years.Her condition is deteriorating and she would like to be sure that this was not related to the implants.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on 24-dec-2021.The most recent information was received on (b)(6) 2021.This spontaneous case was reported by a consumer and describes the occurrence of myalgia ('unexplained muscular pain') in an adult female patient who had essure (batch no.816053) inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: no x-ray or allergy tests performed.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2020, the patient experienced basedow's disease ("basedow's disease (thyroid dysfunction / thyroid problems)").On an unknown date, the patient experienced myalgia (seriousness criterion medically significant), sleep disorder ("sleep disorders"), eye disorder ("eye problems "), fatigue ("fatigue") and disturbance in attention ("loss of concentration") and was found to have weight increased ("weight gain").At the time of the report, the myalgia, sleep disorder, eye disorder, fatigue, disturbance in attention, weight increased and basedow's disease outcome was unknown.The reporter provided no causality assessment for basedow's disease, disturbance in attention, eye disorder, fatigue, myalgia, sleep disorder and weight increased with essure.The reporter commented: numerous health problems over the past 10 years.Her condition is deteriorating and she would like to be sure that this was not related to the implants.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.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 could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 28-dec-2021: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this 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: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj
• MDR Report Key: 13087627
• MDR Text Key: 282774112
• Report Number: 2951250-2021-03649
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2014
• Device Model Number: ESS305
• Device Lot Number: 816053
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2021
• Date Device Manufactured: 01/01/2011
• 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): Other
• Patient Sex: Female