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

[186680182] This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') in an adult female patient who had essure (batch no. B97497) inserted for female sterilization. The occurrence of additional non-serious events is detailed below. The patient's medical history included anxiety, depression, polycystic ovary, infrequent menstruation, polycystic ovaries, miscarriage and amenorrhea. On (b)(6) 2014, the patient had essure inserted. On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), back pain ("back pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), genital swelling ("cervical swelling") and psychological trauma ("psychological trauma") and was found to have weight increased ("weight gain"). The patient was treated with surgery (hysterectomy (full)). Essure treatment was not changed. At the time of the report, the pelvic pain, abdominal pain, back pain, dysmenorrhoea, dyspareunia, weight increased, genital swelling and psychological trauma outcome was unknown. The reporter considered abdominal pain, back pain, dysmenorrhoea, dyspareunia, genital swelling, pelvic pain, psychological trauma and weight increased to be related to essure. The reporter commented: pelvic pain, abdominal pain, back pain, dysmenorrhea (cramping),dyspareunia (painful sexual intercourse), weight gain, cervical swelling, psychological trauma. Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2014: essure confirmation test: (unspecified): results of confirm. Test other< result: unknown. Quality-safety evaluation of ptc: unable to confirm complaint. Most recent follow-up information incorporated above includes: on (b)(6) 2020: pfs received: case became serous incident. Event pt changed- genital swelling. Product lot number was added. Reporter information,medical history were 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: 2951250-2020-02763
• MDR Report Key: 9888640
• Report Source: CONSUMER,OTHER
• Date Received: 2020-03-27
• Date of Report: 2020-04-02
• Date Mfgr Received: 2020-03-05
• Device Manufacturer Date: 2013-11-29
• 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: B97497
• Device Expiration Date: 2016-11-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• 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