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 Emotional Changes (1831)

Event Date 01/01/2014

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ((b)(6), reference number: (b)(4)) on 05-jul-2019.This spontaneous case was reported by a consumer and describes the occurrence of emotional disorder ('my general condition is fragile sensitive to all emotions') in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced emotional disorder (seriousness criterion medically significant), premature ageing ("my body is aging prematurely"), fatigue ("i am always tired"), asthenia ("carrying 2 packs of water becomes too heavy"), pain in extremity ("i pain all over my legs and arms"), dyspepsia ("i have issues with digestion"), amnesia ("i lose my memory"), impatience ("i have no patience"), anger ("i get upset very quickly") and feeling abnormal ("this state that is not like me at all").Essure treatment was not changed.At the time of the report, the emotional disorder, premature ageing, fatigue, asthenia, pain in extremity, dyspepsia, amnesia, impatience, anger and feeling abnormal had not resolved.The reporter considered amnesia, anger, asthenia, dyspepsia, emotional disorder, fatigue, feeling abnormal, impatience, pain in extremity and premature ageing to be related to essure.The reporter commented: events started since the placement of the implants.This state is not like her at all, and then she realized that the only thing that could change her body would be the essure implants.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaints records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm, reference number: (b)(4) on (b)(6) 2019.The most recent information was received on (b)(6) 2019.This spontaneous case was reported by a consumer and describes the occurrence of emotional disorder ('my general condition is fragile sensitive to all emotions') in a 41-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced emotional disorder (seriousness criterion medically significant), premature ageing ("my body is aging prematurely"), fatigue ("i am always tired"), asthenia ("carrying 2 packs of water becomes too heavy"), pain in extremity ("i pain all over my legs and arms"), dyspepsia ("i have issues with digestion"), amnesia ("i lose my memory"), impatience ("i have no patience"), anger ("i get upset very quickly") and feeling abnormal ("this state that is not like me at all").Essure treatment was not changed.At the time of the report, the emotional disorder, premature ageing, fatigue, asthenia, pain in extremity, dyspepsia, amnesia, impatience, anger and feeling abnormal had not resolved.The reporter considered amnesia, anger, asthenia, dyspepsia, emotional disorder, fatigue, feeling abnormal, impatience, pain in extremity and premature ageing to be related to essure.The reporter commented: events started since the placement of the implants.This state is not like her at all, and then she realized that the only thing that could change her body would be the essure implants.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2019: quality safety evaluation of ptc no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We conducted a review of our complaints records and other non-conformances 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
• MDR Report Key: 8773215
• MDR Text Key: 150725478
• Report Number: 2951250-2019-03535
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 07/11/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR