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 Memory Loss/Impairment (1958); Pain (1994); Visual Impairment (2138); Burning Sensation (2146); No Code Available (3191)

Event Date 03/01/2019

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ((b)(6), reference number: (b)(4)) on 25-feb-2020.This spontaneous case was reported by a consumer and describes the occurrence of renal pain ('kidney pain') in a (b)(6) year old female patient who had essure (batch no.772497) inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On (b)(6) 2019, the patient experienced renal pain (seriousness criterion medically significant), vulvovaginal burning sensation ("vaginal burning"), visual impairment ("vision disorder") and memory impairment ("memory disorder").At the time of the report, the renal pain, vulvovaginal burning sensation, visual impairment and memory impairment outcome was unknown.The reporter considered memory impairment, renal pain, visual impairment and vulvovaginal burning sensation to be related to essure.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

This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on (b)(6) 2020.The most recent information was received on 23-mar-2020.This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ('medical device removal') and renal pain ('kidney pain') in a 52-year-old female patient who had essure (batch no.772497) inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On (b)(6) 2019, the patient experienced renal pain (seriousness criterion medically significant), vulvovaginal burning sensation ("vaginal burning"), visual impairment ("vision disorder") and memory impairment ("memory disorder").On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced tendonitis ("tendonitis").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2011.At the time of the report, the medical device removal, renal pain, vulvovaginal burning sensation, visual impairment, memory impairment and tendonitis outcome was unknown.The reporter provided no causality assessment for tendonitis with essure.The reporter considered medical device removal, memory impairment, renal pain, visual impairment and vulvovaginal burning sensation to be related to essure.The reporter commented: date of onset: (b)(6) 2011 and period of onset: 3 weeks after insertion.The consumer stated she was badly affected because of all of the problems caused by this implant.Lot number: 772497, manufacturing date: 2010-08, expiration date: 2013-08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: essure removal date provided.Events tendonitis and medical device removal added.The event kidney pain was updated to non-serious incident.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.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on (b)(6) 2020.The most recent information was received on 11-mar-2020.This spontaneous case was reported by a consumer and describes the occurrence of renal pain ('kidney pain') in a 52-year-old female patient who had essure (batch no.772497) inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On (b)(6) 2019, the patient experienced renal pain (seriousness criterion medically significant), vulvovaginal burning sensation ("vaginal burning"), visual impairment ("vision disorder") and memory impairment ("memory disorder").At the time of the report, the renal pain, vulvovaginal burning sensation, visual impairment and memory impairment outcome was unknown.The reporter considered memory impairment, renal pain, visual impairment and vulvovaginal burning sensation to be related to essure.Lot number: 772497, manufacturing date: 2010-08, expiration date: 2013-08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-mar-2020: quality safety evaluation of ptc.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.

• 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: 9758904
• MDR Text Key: 187685260
• Report Number: 2951250-2020-01741
• 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,Followup
• Report Date: 03/27/2020

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 Expiration Date: 08/01/2013
• Device Model Number: ESS305
• Device Lot Number: 772497
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 02/25/2020; 03/11/2020
• Supplement Dates FDA Received: 03/12/2020; 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52 YR