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); Cyst(s) (1800); Emotional Changes (1831); Headache (1880); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Blurred Vision (2137); Depression (2361); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of genital haemorrhage ('gen.Abnorm.Bleed') 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 ectopic pregnancy from 2007 to 2008, anemia (treatment: blood transfusion, iron pills and stool softener) from (b)(6) 2005 to 2008, salpingectomy and ectopic pregnancy.Previously administered products included for prevent pregnancy: depo-provera from (b)(6) 2008 to (b)(6) 2008.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), dyspareunia ("dyspareunia (painful sexual intercourse),"), dysmenorrhoea ("dysmennorhea (cramping)"), abdominal pain ("pelvic/ abdominal pain"), pelvic pain ("pelvic/ abdominal pain"), back pain ("back pain"), metrorrhagia ("metorhagia (bleeding b/w periods),"), bladder disorder ("bladder probs"), urinary tract disorder ("urinary probs"), urinary tract infection ("uti"), vaginal discharge ("vag.Discharge"), gastrointestinal disorder ("gi conditions"), tooth disorder ("dental probs.,"), headache ("headaches,"), nausea ("nausea"), vision blurred ("vision probs, blurred"), mood swings ("mood swings"), vaginal haemorrhage ("vaginal bleeding"), menorrhagia ("menorrhagia"), depression ("depression"), migraine ("migraines") and ovarian cyst ("ovarian cysts") and was found to have weight increased ("weight gain").Essure treatment was not changed.At the time of the report, the genital haemorrhage, dyspareunia, dysmenorrhoea, abdominal pain, pelvic pain, back pain, metrorrhagia, bladder disorder, urinary tract disorder, urinary tract infection, vaginal discharge, gastrointestinal disorder, tooth disorder, headache, nausea, vision blurred, weight increased, mood swings, vaginal haemorrhage, menorrhagia, depression, migraine and ovarian cyst outcome was unknown.The reporter considered abdominal pain, back pain, bladder disorder, depression, dysmenorrhoea, dyspareunia, gastrointestinal disorder, genital haemorrhage, headache, menorrhagia, metrorrhagia, migraine, mood swings, nausea, ovarian cyst, pelvic pain, tooth disorder, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, vision blurred and weight increased to be related to essure.The reporter commented: she received treatment for bladder problems, urinary problems, uti, vaginal discharge.Insertion date discrepancy: (b)(6) 2008/(b)(6) 2008.Essure hysteroscopic sterilization procedure: findings: an ante flexed uterus that was mobile and nontender.The uterine cavity was normal in appearance and atrophic with easy visualization of the ostia.Operative note: the left tubal ostium was easily visualized.The essure device was then advanced in the tubal ostium and deployed as recommended.There were three coils noted extending from the ostium.The patient tolerated the procedure well.Diagnostic results (normal ranges are provided in parenthesis if available): hysteroscopy on an unknown date: an ante flexed uterus that was mobile and nontender.The uterine cavity was normal in appearance and atrophic with easy visualization of the ostia.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-mar-2020: new events were added: blurred vision, mood swings, vaginal bleeding, menorrhagia, depression, migraines and ovarian cysts.Medical history was added.Insertion date discrepancy: (b)(6) 2008/(b)(6) 2008.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: 9912616
• MDR Text Key: 196593394
• Report Number: 2951250-2020-02867
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• 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
• Date Manufacturer Received: 12/06/2018
• 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