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); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain ('abdomen pain') and genital haemorrhage ('abnormal bleeding (general)') 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 fitz-hugh-curtis syndrome, multigravida and miscarriage.Concurrent conditions included body mass index normal.In (b)(6) 2014, the patient had essure inserted.In 2016, the patient experienced alopecia ("hair loss") and blood disorder ("changes in blood").On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary tract disorder"), migraine ("migraines /headaches"), anaemia ("blood or heart disorder/condition type: anemia"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), eye disorder ("vision/eye problems") and fatigue ("fatigue") and was found to have hormone level abnormal ("hormonal changes describe: constantly on edge"), weight increased ("weight gain / loss (specify which one) / weight gain") and protein urine present ("protein in urine").The patient was treated with iron and surgery (da vinci total laparoscopic hysterectomy, bilateral salpingectomy and lysis of adhesions.).Essure was removed on (b)(6) 2018.At the time of the report, the abdominal pain, genital haemorrhage, hormone level abnormal, vaginal haemorrhage, menorrhagia, female sexual dysfunction, bladder disorder, urinary tract disorder, migraine, anaemia, nausea, dysmenorrhoea, dyspareunia, eye disorder, fatigue, weight increased, alopecia, protein urine present and blood disorder outcome was unknown.The reporter considered abdominal pain, alopecia, anaemia, bladder disorder, blood disorder, dysmenorrhoea, dyspareunia, eye disorder, fatigue, female sexual dysfunction, genital haemorrhage, hormone level abnormal, menorrhagia, migraine, nausea, protein urine present, urinary tract disorder, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: current weight (b)(6).On (b)(6) 2018, surgical pathology: benign endometrium with secretory features.Myometrium: no significant histopathology change.Fallopian tubes: essure coil identified within the left fallopian tube.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6).X-ray - in (b)(6) 2014: total bilateral occlusion.¿concerning the injuries reported in this case, the following ones were described in patients medical record: dyspareunia, dysmenorrhea and menorrhagia".Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-sep-2019: the case was updated from other event to incident.Essure removal date was added.Reporter information and medical history was added.

• 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: 9201329
• MDR Text Key: 173226614
• Report Number: 2951250-2019-10338
• 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: 10/17/2019

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: 09/26/2019
• Initial Date FDA Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 64