MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Anemia (1706); Cyst(s) (1800); Nausea (1970); Pain (1994); Abnormal Vaginal Discharge (2123); Depression (2361); Unspecified Gastrointestinal Problem (4491); Hormonal Imbalance (4495); Dyspareunia (4505); Menorrhagia (4508)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('menorrhagia (heavy menstrual bleeding)') 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 "she did not undergo essure confirmation test".On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced menorrhagia (seriousness criterion medically significant), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), back pain ("back pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), iron deficiency anaemia ("anemia"), vaginal discharge ("vaginal discharge"), gastrointestinal disorder ("gi condition"), nausea ("nausea"), cyst ("cysts"), depression ("depression / psych injury") and anxiety ("anxiety") and was found to have hormone level abnormal ("hormonal changes").Essure treatment was not changed.At the time of the report, the menorrhagia, pelvic pain, abdominal pain, back pain, dysmenorrhoea, dyspareunia, iron deficiency anaemia, vaginal discharge, gastrointestinal disorder, hormone level abnormal, nausea, cyst, depression and anxiety outcome was unknown.The reporter considered abdominal pain, anxiety, back pain, cyst, depression, dysmenorrhoea, dyspareunia, gastrointestinal disorder, hormone level abnormal, iron deficiency anaemia, menorrhagia, nausea, pelvic pain and vaginal discharge to be related to essure.The reporter commented: plaintiff received treatment for menorrhagia (heavy menstrual bleeding), anemia, anxiety depression, gi conditions, hormonal changes, nausea, cysts, depression and anxiety.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: this case was deleted from pv bayer database.As this case (b)(4) was found to be duplicated of case no (b)(4) all the information from deletion case was transferred to retain case.No new follow-up information was received from the reporter.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, NJ 07981
• MDR Report Key: 10605365
• MDR Text Key: 209135446
• Report Number: 2951250-2020-14720
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other