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 Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Muscular Rigidity (1968); Pain (1994); Visual Impairment (2138); Sweating (2444); Weight Changes (2607)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ((b)(6), reference number: (b)(4)) on 29-dec-2020.This spontaneous case was reported by a consumer and describes the occurrence of back pain ('back pain') in a female patient who had essure (batch no.626280) inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced back pain (seriousness criterion medically significant), abdominal pain upper ("stomach pain"), fatigue ("severe fatigue"), abnormal weight gain ("heavy weight gain"), alopecia ("hair loss"), hyperhidrosis ("heavy sweating"), menorrhagia ("heavy periods"), pruritus ("itchy hands"), pain ("pain all over the body"), musculoskeletal disorder ("difficulty moving"), visual impairment ("decreased eyesight") and aggression ("aggressive moods").Essure treatment was not changed.At the time of the report, the back pain, abdominal pain upper, fatigue, abnormal weight gain, alopecia, hyperhidrosis, menorrhagia, pruritus, pain, musculoskeletal disorder, visual impairment and aggression outcome was unknown.The reporter provided no causality assessment for abdominal pain upper, abnormal weight gain, aggression, alopecia, back pain, fatigue, hyperhidrosis, menorrhagia, musculoskeletal disorder, pain, pruritus and visual impairment with essure.The reporter commented: that she has inability to work outside her home.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 29-dec-2020.This spontaneous case was reported by a consumer and describes the occurrence of back pain ('back pain') in a female patient who had essure (batch no.626280) inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced back pain (seriousness criterion medically significant), abdominal pain upper ("stomach pain"), fatigue ("severe fatigue"), abnormal weight gain ("heavy weight gain"), alopecia ("hair loss"), hyperhidrosis ("heavy sweating"), menorrhagia ("heavy periods"), pruritus ("itchy hands"), pain ("pain all over the body"), musculoskeletal disorder ("difficulty moving"), visual impairment ("decreased eyesight") and aggression ("aggressive moods").Essure treatment was not changed.At the time of the report, the back pain, abdominal pain upper, fatigue, abnormal weight gain, alopecia, hyperhidrosis, menorrhagia, pruritus, pain, musculoskeletal disorder, visual impairment and aggression outcome was unknown.The reporter provided no causality assessment for abdominal pain upper, abnormal weight gain, aggression, alopecia, back pain, fatigue, hyperhidrosis, menorrhagia, musculoskeletal disorder, pain, pruritus and visual impairment with essure.The reporter commented: that she has inability to work outside her home.Lot number: 626280, manufacturing date: 2007/12, expiration date: 2009/11.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 8-jan-2021: 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
• MDR Report Key: 11107105
• MDR Text Key: 231953153
• Report Number: 2951250-2021-00023
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2009
• Device Model Number: ESS305
• Device Lot Number: 626280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other