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

Model Number ESS205

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

Patient Problem Myalgia (2238)

Event Date 01/01/2009

Event Type  Injury  

Event Description

The below report was received by health authority ansm (reference number: (b)(4)) on 01-mar-2023.This spontaneous case was originally reported by a consumer and describes the occurrence of musculoskeletal pain ("joint and muscle pain") in an adult female patient who had essure (ess205) inserted (lot no.621805, 620727) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2007, the patient had essure (ess205) inserted.In 2009 she experienced musculoskeletal pain (seriousness criterion medically important), tendonitis ("tendinitis of the shoulders and elbows"), rotator cuff syndrome ("tendinitis of the shoulders and elbows"), neck pain ("neck pain"), sleep disorder ("sleep disorder"), asthenia ("asthenia"), eczema ("auditory canal itching"), cough ("recurrent dry cough"), aphasia ("memory disorder with difficulty finding words"), constipation ("constipation"), pain in extremity ("pain in the hands") and meniscus injury ("meniscus micro-fracture without any impact").An unknown time later she experienced burnout syndrome ("burn out").No causality assessment was received for essure (ess205) with regard to tendonitis, rotator cuff syndrome, neck pain, musculoskeletal pain, sleep disorder, asthenia, eczema, cough, aphasia, constipation, pain in extremity, meniscus injury or burnout syndrome.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 69 kg.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

The below report was received by health authority ansm (reference number: (b)(4)) on 01-mar-2023.The most recent information was received on 09-mar-2023.This spontaneous case was originally reported by a consumer and describes the occurrence of musculoskeletal pain ("joint and muscle pain") in an adult female patient who had essure (ess205) inserted (lot no.620727, 621805) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2007, the patient had essure (ess205) inserted.In 2009 she experienced musculoskeletal pain (seriousness criterion medically important), tendonitis ("tendinitis of the shoulders and elbows"), rotator cuff syndrome ("tendinitis of the shoulders and elbows"), neck pain ("neck pain"), sleep disorder ("sleep disorder"), asthenia ("asthenia"), eczema ("auditory canal itching"), cough ("recurrent dry cough"), aphasia ("memory disorder with difficulty finding words"), constipation ("constipation"), pain in extremity ("pain in the hands") and meniscus injury ("meniscus micro-fracture without any impact").An unknown time later she experienced burnout syndrome ("burn out").No causality assessment was received for essure (ess205) with regard to tendonitis, rotator cuff syndrome, neck pain, musculoskeletal pain, sleep disorder, asthenia, eczema, cough, aphasia, constipation, pain in extremity, meniscus injury or burnout syndrome.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 69 kg.Lot number: 620727, manufacture date: 2006-07, and expiration date: 2008-04.Lot number: 621805, manufacture date: 2006-12, and expiration date: 2008-11.Quality-safety evaluation of ptc: for essure (ess205): 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.The most recent follow-up information incorporated above includes data received on: 09-mar-2023: quality safety evaluation of ptc.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: 16485991
• MDR Text Key: 310703139
• Report Number: 2951250-2023-00944
• 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: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2008
• Device Model Number: ESS205
• Device Lot Number: 620727, 621805
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2023
• Date Device Manufactured: 07/01/2006
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 69 KG