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 11-mar-2022.This spontaneous case was reported by a consumer and describes the occurrence of myalgia ('muscle pain') in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced myalgia (seriousness criterion medically significant) and tendonitis ("tendinitis") and was found to have breath sounds abnormal ("murmur breathing").Essure treatment was not changed.At the time of the report, the myalgia, tendonitis and breath sounds abnormal outcome was unknown.The reporter provided no causality assessment for breath sounds abnormal, myalgia and tendonitis with essure.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be (b)(6).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 11-mar-2022.The most recent information was received on 17-mar-2022.This spontaneous case was reported by a consumer and describes the occurrence of myalgia ('muscle pain') in a 50-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced myalgia (seriousness criterion medically significant) and tendonitis ("tendinitis") and was found to have breath sounds abnormal ("murmur breathing").Essure treatment was not changed.At the time of the report, the myalgia, tendonitis and breath sounds abnormal outcome was unknown.The reporter provided no causality assessment for breath sounds abnormal, myalgia and tendonitis with essure.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 70 kgs.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 17-mar-2022: 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: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj
• MDR Report Key: 13756925
• MDR Text Key: 290545644
• Report Number: 2951250-2022-00213
• 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: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• 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: 03/17/2022
• 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 Age: 50 YR
• Patient Sex: Female
• Patient Weight: 70 KG