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 Rash (2033)

Event Date 08/12/2021

Event Type  Injury  

Event Description

The below report was received by health authority ansm (reference number: (b)(4)), on (b)(6) 2023.This spontaneous case was originally reported by a consumer, and describes the occurrence of rash ("rash") in a 46 year-old female patient who had essure inserted (lot no.C68792).Additional non-serious events are detailed below: there was no information on the patient's medical history or concurrent conditions.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2021, 2260 days after essure insertion, she experienced rash (seriousness criterion intervention required), myalgia ("permanent muscle pain"), fatigue ("chronic fatigue"), arthralgia ("pain in hip bones"), amnesia ("memory loss"), disturbance in attention ("difficulty concentrating") and depression ("depression").The patient was treated with surgery ( device removal is scheduled in 1 month).Essure treatment was not changed.At the time of the report, the outcomes for these events were unknown.The reporter considered amnesia, arthralgia, depression, disturbance in attention, fatigue, myalgia and rash to be related to essure administration.The reporter commented: the device removal is scheduled in 1 month.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 73 kg.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

The below report was received by health authority ansm (reference number: (b)(4)) on 02-jun-2023.The most recent information was received on 20-jun-2023.This spontaneous case was originally reported by a consumer and describes the occurrence of rash ("rash") in a 46 year-old female patient who had essure inserted (lot no.C68792).Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2021, 2260 days after essure insertion, she experienced rash (seriousness criterion intervention required), myalgia ("permanent muscle pain"), fatigue ("chronic fatigue"), arthralgia ("pain in hip bones"), amnesia ("memory loss"), disturbance in attention ("difficulty concentrating") and depression ("depression").The patient was treated with surgery (device removal is scheduled in 1 month).Essure treatment was not changed.At the time of the report, the outcomes for these events were unknown.The reporter considered amnesia, arthralgia, depression, disturbance in attention, fatigue, myalgia and rash to be related to essure administration.The reporter commented: the device removal is scheduled in 1 month.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 73 kg.Batch no: c68792, production date: 2014-06-24, and expiration date: 2017-06-30.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: 20-jun-2023: 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: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 17082143
• MDR Text Key: 316841445
• Report Number: 2951250-2023-02603
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: ESS305
• Device Lot Number: C68792
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2023
• Date Device Manufactured: 06/24/2014
• 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): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 73 KG