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 2020-03-26 for ESSURE ESS305 manufactured by Bayer Pharma Ag.

Event Text Entries

[185912579] This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic cramps') in an adult female patient who had essure inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. Other product or product use issues identified: device monitoring procedure not performed "device monitoring procedure not performed". The patient's previously administered products included for an unreported indication: iud nos. In 2014, the patient had essure inserted. On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), nausea ("nauseous"), back pain ("back pain") and mental disorder ("psychological is condition order") and was found to have weight increased ("weight gain"). The patient was treated with surgery (bilateral salpingectomy). Essure was removed on (b)(6) 2017. At the time of the report, the pelvic pain and back pain was resolving, the weight increased and mental disorder outcome was unknown and the nausea had resolved. The reporter considered back pain, mental disorder, nausea, pelvic pain and weight increased to be related to essure. The reporter commented: discrepancy noted in essure insertion date as 2015. Current weight: (b)(6). Most recent follow-up information incorporated above includes: on (b)(6) 2020: pfs received: case become incident. Events: weight gain, nauseous, back pain, pelvic cramps were added. Reporters, patients demographics, essure removal and insertion date were added. Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2951250-2020-02745
• MDR Report Key: 9883203
• Report Source: CONSUMER,OTHER
• Date Received: 2020-03-26
• Date of Report: 2020-03-26
• Date Mfgr Received: 2018-03-05
• Date Added to Maude: 2020-03-26
• 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: 2020-03-26
• Model Number: ESS305
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: *
• 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	2020-03-26