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 Myalgia (2238); Insufficient Information (4580)

Event Date 06/19/2023

Event Type  Injury  

Event Description

The below report was received by health authority ansm (reference number: (b)(4)) on 23-feb-2023.The most recent information was received on 14-mar-2023.This spontaneous case was originally reported by a consumer and describes the occurrence of musculoskeletal pain ("muscle and joint pain appearing progressively over the years") in a female patient who had essure inserted.There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient had essure inserted.On an unknown date she experienced musculoskeletal pain (seriousness criterion medically important).At the time of the report, the outcome of the event was unknown.No causality assessment was received for essure with regard to musculoskeletal pain.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 70 kg.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: 14-mar-2023: quality-safety evaluation of ptc.After internal review, the case was upgraded to serious incident.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

The below report was received by health authority ansm (reference number: (b)(4)) on 23-feb-2023.The most recent information was received on 01-apr-2023.This spontaneous case was originally reported by a consumer and describes the occurrence of musculoskeletal pain ("muscle and joint pain appearing progressively over the years") in a female patient who had essure inserted.There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient had essure inserted.On an unknown date she experienced musculoskeletal pain (seriousness criterion medically important).At the time of the report, the outcome of the event was unknown.No causality assessment was received for essure with regard to musculoskeletal pain.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 70 kg.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: 01-apr-2023: 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

The below report was received by health authority ansm (reference number: (b)(4)) on 23-feb-2023.The most recent information was received on 29-jan-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of medical device removal ("medical device removal") and arthralgia ("muscle and joint pain appearing progressively over the years") in a female patient who had essure inserted.Additional non-serious events are detailed below.Product or product use issues identified: inappropriate insertion of multiple contraceptive devices ("the gynaecologist fitted me with 3 implants instead of 2 in 2009" in 2010).There was no information on the patient's medical history or concurrent conditions.On 24-jul-2009, the patient had essure inserted.In 2010 she experienced arthralgia (seriousness criterion medically important), myalgia ("diffuse muscle"), fatigue ("severe fatigue"), visual impairment ("eyesight problems"), ear, nose and throat disorder ("ear-nose-throat (ent) problems") and memory impairment ("memory problems").On 19-jun-2023 she underwent medical device removal (seriousness criterion intervention required).Essure was removed the same day.The patient was treated with surgery (to remove essure).At the time of the report, the arthralgia and fatigue had not resolved.The outcomes for medical device removal, myalgia, visual impairment, ear, nose and throat disorder and memory impairment were unknown.No causality assessment was received for essure with regard to arthralgia, myalgia, fatigue, visual impairment, ear, nose and throat disorder, memory impairment or medical device removal.The reporter commented: muscle and joint pain everywhere in the body, severe fatigue, eyesight problems despite device removal.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 70 kg.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: 29-jan-2024: new events medical device removal , diffuse muscle, fatigue, ear nose & throat disorder, memory problems are added.Event outcome , event onset date , essure removal surgery name , date & details updated.Action taken with drug added.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: 16572305
• MDR Text Key: 311577824
• Report Number: 2951250-2023-01425
• Device Sequence Number: 1
• Product Code: HHS
• 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,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• 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: 01/29/2024
• 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): Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 70 KG