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

[186283200] This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') and ovarian cyst ('ovarian cyst') in an adult female patient who had essure (batch no. 556676) inserted for female sterilisation. The patient's medical history included c-section. On (b)(6) 2011, the patient had essure inserted. On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and ovarian cyst (seriousness criterion medically significant). The patient was treated with surgery (hysterectomy (partial) and surgery (other) type of surgery: ovarian cyst removal). Essure treatment was ongoing at the time of the report. At the time of the report, the pelvic pain and ovarian cyst outcome was unknown. The reporter considered ovarian cyst and pelvic pain to be related to essure. The reporter commented: the essure device was first placed in the patient's right tubal ostia. The coils were out to the black mark, per manufacturer specifications. The device was then activated and deployed via manufacturer's commendations. Just the very distal end of coil was visible. Attention was then turned to the left side, which in a similar fashion was cannulated up to the black mark. Device was activated per manufacturer specifications and approximately 3 coils were visible. Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on an unknown date: not reported. Most recent follow-up information incorporated above includes: on (b)(6) 2020: pfs+mr received. Lot number added. Event injury was updated and new events "pelvic pain" and "ovarian cyst "added. Removal details added. New reporters, plaintiffs information added. Past medical history and 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: 2951250-2020-02778
• MDR Report Key: 9889771
• Report Source: CONSUMER,OTHER
• Date Received: 2020-03-27
• Date of Report: 2020-04-02
• Date Mfgr Received: 2020-03-05
• 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: 556676-NOT VALID
• 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