ESSURE ESS305

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2020-03-27 for ESSURE ESS305 manufactured by Bayer Pharma Ag.

Event Text Entries

[188719563] This case was initially received via regulatory authority (reference number: (b)(4)) on 26-mar-2020. This spontaneous case was reported by a consumer and describes the occurrence of skin disorder ('dermatological disorder') in an adult female patient who had essure (batch no. A47950) 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 skin disorder (seriousness criterion medically significant), fatigue ("general fatigue"), rhinorrhoea ("nasal discharge"), endocrine disorder ("endocrine problems"), premature menopause ("early menopause"), feeling of body temperature change ("hot or cold"), hyperhidrosis ("sweating"), nervous system disorder ("nervous system disorder"), gastrointestinal disorder ("gastrointestinal disorder"), visual impairment ("vison disorder"), musculoskeletal disorder ("musculoskeletal disorder") and depression ("depressive tendency") and was found to have heart rate abnormal ("heart rate disorder"). Essure treatment was not changed. At the time of the report, the skin disorder, fatigue, rhinorrhoea, endocrine disorder, premature menopause, feeling of body temperature change, hyperhidrosis, heart rate abnormal, nervous system disorder, gastrointestinal disorder, visual impairment, musculoskeletal disorder and depression outcome was unknown. The reporter provided no causality assessment for depression, endocrine disorder, fatigue, feeling of body temperature change, gastrointestinal disorder, heart rate abnormal, hyperhidrosis, musculoskeletal disorder, nervous system disorder, premature menopause, rhinorrhoea, skin disorder and visual impairment with essure. The reporter commented: treatment drug: nonsteroidal anti-inflammatory. Difficulty keeping her job; difficulties maintaining her daily life at home; blood tests and x-rays are scheduled; to be performed prior to planning removal. A lot number was received 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2951250-2020-02784
• MDR Report Key: 9892213
• Report Source: CONSUMER,FOREIGN,OTHER
• Date Received: 2020-03-27
• Date of Report: 2020-04-01
• Date of Event: 2013-01-01
• Date Mfgr Received: 2020-03-26
• Device Manufacturer Date: 2012-09-01
• Date Added to Maude: 2020-03-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: K SHAW LAMBERSON
• Manufacturer Street: 100 BAYER BLVD, P.O. BOX 915
• Manufacturer City: WHIPPANY NJ 07981
• Manufacturer Country: US
• Manufacturer Postal: 07981
• Manufacturer G1: BAYER PHARMA AG
• Manufacturer Street: M
• Manufacturer City: BERLIN, 13353
• Manufacturer Country: GM
• Manufacturer Postal Code: 13353
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ESSURE
• Generic Name: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Product Code: HHS
• Date Received: 2020-03-27
• Model Number: ESS305
• Lot Number: A47950
• Device Expiration Date: 2015-09-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAYER PHARMA AG
• Manufacturer Address: M?LLERSTR. 178 BERLIN, 13353 GM 13353

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-03-27