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); Emotional Changes (1831); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Rash (2033); Abnormal Vaginal Discharge (2123); Weight Changes (2607); Heavier Menses (2666)

Event Date 01/01/2010

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.The patient's medical history included overweight.In (b)(6) 2009, the patient had essure inserted.In 2010, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), nausea ("nausea"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and dysmenorrhoea ("dysmenorrhea (cramping)").In 2013, the patient experienced mood swings ("hormonal changes describe: mood swings"), vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type: yeast") and abdominal pain lower ("pain in lower abdomen").In 2015, the patient experienced rash papular ("rashes or skin conditions type: red bumps on both legs") and migraine ("migraines / headaches").In 2016, the patient experienced visual impairment ("vision/eye problems type: decrease in sight").On an unknown date, the patient experienced genital haemorrhage ("gen.Abnorm.Bleed"), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), iron deficiency anaemia ("anemia"), bladder disorder ("bladder probs"), vaginal discharge ("vaginal discharge"), vaginal infection ("vaginal infection"), fatigue ("fatigue"), gastrointestinal disorder ("gi conditions"), dermatitis allergic ("rash/skin condition") and psychological trauma ("psych injury related to essure") and was found to have hormone level abnormal ("hormonal changes") and weight increased ("weight gain").The patient was treated with surgery (ablation).Essure treatment was not changed.At the time of the report, the menorrhagia, genital haemorrhage, dyspareunia, pelvic pain, abdominal pain, iron deficiency anaemia, bladder disorder, vaginal discharge, vaginal infection, fatigue, gastrointestinal disorder, hormone level abnormal, nausea, visual impairment, weight increased, dermatitis allergic, psychological trauma, mood swings, vaginal haemorrhage, vulvovaginal mycotic infection, rash papular, migraine, dysmenorrhoea and abdominal pain lower outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, bladder disorder, dermatitis allergic, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal disorder, genital haemorrhage, hormone level abnormal, iron deficiency anaemia, menorrhagia, migraine, mood swings, nausea, pelvic pain, psychological trauma, rash papular, vaginal discharge, vaginal haemorrhage, vaginal infection, visual impairment, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: the plantiff received treatment for menorrhagia, iron deficiency anaemia, genital haemorrhage, bladder disorder, vaginal discharge, vaginal infection.If essure removal not planned, select reason(s): unable to afford surgery.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 29.6 kg/sqm.Hysterosalpingogram on (b)(6) 2009: total bilateral occlusion.Imaging procedure on (b)(6) 2009: essure confirmation test(s) (unspecified) bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-dec-2019: pfs and mr received: reporter added.Essure insertion date updated.New events hormonal changes describe: mood swings, abnormal bleeding (vaginal), infection (bladder/ urinary tract/vaginal) type: yeast, rashes or skin conditions type: red bumps on both legs, migraines / headaches, dysmenorrhea (cramping), vision/eye problems type: decrease in sight, pain in lower abdomen 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.

• 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: 9580137
• MDR Text Key: 177183769
• Report Number: 2951250-2020-00413
• 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: 01/13/2020

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: 12/26/2019
• Initial Date FDA Received: 01/13/2020
• 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; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 77