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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Emotional Changes (1831)

Event Date 01/01/2014

Event Type  Injury  

Event Description

The below report was received by health authority ansm (reference number: (b)(6)) on 2-sep-2023.The most recent information was received on 12-feb-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of emotional disorder ("disproportionate emotional reactions") in a 46 year-old female patient who had essure inserted (lot no.B15014).Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2014 she experienced emotional disorder (seriousness criterion medically important), fatigue ("chronic severe fatigue"), rotator cuff syndrome ("tendinitis in the shoulders"), tendon rupture ("ruptured tendon in left shoulder"), candida infection ("candidiasis"), intestinal barrier dysfunction ("leaky gut"), arthropathy ("joint disorders in wrists and knees"), paraesthesia ("tingling in the arms"), burning sensation ("burning sensation all over the body"), hemiparesis ("weakness on the entire left-hand side of the body: foot, knee, hip, shoulder"), insomnia ("insomnia"), aphasia ("difficulty finding words"), memory impairment ("impaired memory"), anxiety ("severe anxiety") and disturbance in attention ("difficulty concentrating").Essure.At the time of the report, the fatigue, rotator cuff syndrome and tendon rupture had not resolved.No causality assessment was received for essure with regard to fatigue, rotator cuff syndrome, tendon rupture, candida infection, intestinal barrier dysfunction, arthropathy, paraesthesia, burning sensation, hemiparesis, insomnia, aphasia, memory impairment, anxiety, disturbance in attention or emotional disorder.The reporter commented: patient¿s current status: chronic fatigue, tendinitis and ruptured tendon in left shoulder.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 62 kg.Lot number: b15014 manufacture date: 2013-04 expiration date: 2016-04.Quality-safety evaluation of ptc: for essure: unable to confirm complaint the most recent follow-up information incorporated above includes data received on: 12-feb-2024: quality safety evaluation of ptc.After internal review, this case was upgraded to serious incident.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 28-sep-2023.The most recent information was received on 16-feb-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of emotional disorder ("disproportionate emotional reactions") in a 46 year-old female patient who had essure inserted (lot no.B15014).Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2014 she experienced emotional disorder (seriousness criterion medically important), fatigue ("chronic severe fatigue"), shoulder tendinitis ("tendinitis in the shoulders"), rotator cuff tear ("ruptured tendon in left shoulder"), candida infection ("candidiasis"), intestinal barrier dysfunction ("leaky gut"), arthropathy ("joint disorders in wrists and knees"), paraesthesia ("tingling in the arms"), burning sensation ("burning sensation all over the body"), hemiparesis ("weakness on the entire left-hand side of the body: foot, knee, hip, shoulder"), insomnia ("insomnia"), aphasia ("difficulty finding words"), memory impairment ("impaired memory"), anxiety ("severe anxiety") and disturbance in attention ("difficulty concentrating").Essure.At the time of the report, the fatigue, shoulder tendinitis and rotator cuff tear had not resolved.No causality assessment was received for essure with regard to fatigue, shoulder tendinitis, rotator cuff tear, candida infection, intestinal barrier dysfunction, arthropathy, paraesthesia, burning sensation, hemiparesis, insomnia, aphasia, memory impairment, anxiety, disturbance in attention or emotional disorder.The reporter commented: patient¿s current status: chronic fatigue, tendinitis and ruptured tendon in left shoulder.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 62 kg.Lot number: b15014; manufacture date: 2013-04; expiration date: 2016-04.Quality-safety evaluation of ptc: for essure: 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: 16-feb-2024: 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: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 18711341
• MDR Text Key: 335471563
• Report Number: 2951250-2024-00111
• 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
• Report Date: 02/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Model Number: ESS305
• Device Lot Number: B15014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2024
• Date Device Manufactured: 04/01/2013
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 62 KG