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

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Skin Irritation (2076); Swelling (2091); Anxiety (2328); Arthralgia (2355); Malaise (2359); Depression (2361); Confusion/ Disorientation (2553); Heavier Menses (2666)

Event Date 01/01/2017

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (fda, reference number: mw5081415) on 30-nov-2018.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("heavy period"), amnesia ("memory loss") and autoimmune disorder ("potential autoimmune disorder") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.In 2013, the patient experienced amnesia (seriousness criterion disability), paranoia ("paranoia"), anxiety ("anxiety"), disturbance in attention ("concentration /focus issue") and mood swings ("mood swings").In 2017, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), dysmenorrhoea ("painful period"), abdominal pain upper ("painful stomach"), arthralgia ("joint pain") and somnolence ("sometimes needing 12-18 hours of sleep per day").On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant), depression ("depression"), feeling abnormal ("brain fog"), vitamin d deficiency ("very low vitamin d"), fatigue ("constant fatigue"), alopecia ("hair loss"), rash macular ("dry red patches"), dry skin ("dry skin"), skin atrophy ("thin skin"), skin disorder ("wrinkled skin"), malaise ("malaise"), tooth disorder ("multiple teeth having degradation") and swelling ("swelling during ovulation") and was found to have white blood cell count increased ("higher white blood cell count ").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2018.At the time of the report, the menorrhagia, amnesia, autoimmune disorder, paranoia, anxiety, depression, feeling abnormal, disturbance in attention, mood swings, vitamin d deficiency, fatigue, alopecia, rash macular, dry skin, skin atrophy, skin disorder, malaise, white blood cell count increased, tooth disorder, dysmenorrhoea, abdominal pain upper, swelling, arthralgia and somnolence outcome was unknown.The reporter provided no causality assessment for abdominal pain upper, alopecia, amnesia, anxiety, arthralgia, autoimmune disorder, depression, disturbance in attention, dry skin, dysmenorrhoea, fatigue, feeling abnormal, malaise, menorrhagia, mood swings, paranoia, rash macular, skin atrophy, skin disorder, somnolence, swelling, tooth disorder, vitamin d deficiency and white blood cell count increased with essure.Incident 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 complaint 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
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, NJ 07981
• MDR Report Key: 8176038
• MDR Text Key: 130778906
• Report Number: 2951250-2018-05143
• 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,other
• Type of Report: Initial
• Report Date: 12/18/2018

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
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/18/2018
• 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; Required Intervention