ESSURE ESS305

MAUDE Adverse Event Report

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

Event Text Entries

[188719974] This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain lower ('left side lower abdominal pain') in a (b)(6) year old female patient who had essure (batch no. A50510) inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. On (b)(6) 2013, the patient had essure inserted. In (b)(6) 2016, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"). On (b)(6) 2016, the patient experienced migraine ("migraines / headaches"), 3 years 8 months after insertion of essure. In (b)(6) 2017, the patient experienced urinary tract disorder ("urinary problems") and bladder disorder ("bladder problems"). On (b)(6) 2018, the patient was found to have cystoscopy ("cystoscopy"). On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required). The patient was treated with surgery (bilateral salpingectomy). Essure was removed on (b)(6) 2018. At the time of the report, the abdominal pain lower and dyspareunia had resolved and the migraine, urinary tract disorder, bladder disorder and cystoscopy outcome was unknown. The reporter considered abdominal pain lower, bladder disorder, cystoscopy, dyspareunia, migraine and urinary tract disorder to be related to essure. Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram on (b)(6) 2013: total bilateral occlusion. Most recent follow-up information incorporated above includes: on 5-mar-2020: pfs received : previously reported event "injury to herself" updated to "dyspareunia (painful sexual intercourse)", events- "migraines / headaches, urinary problems, bladder problems, left side lower abdominal pain and cystoscopy", reporter, lot number, lab data added. 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2951250-2020-02764
• MDR Report Key: 9888632
• Report Source: CONSUMER,OTHER
• Date Received: 2020-03-27
• Date of Report: 2020-04-03
• Date Mfgr Received: 2020-03-05
• 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: A50510
• 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; 2. Required No Informationntervention	2020-03-27