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

Model Number ESS305

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Pain (1994); Confusion/ Disorientation (2553); Pregnancy (3193)

Event Type  Injury  

Event Description

This prospective pregnancy case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain"), device dislocation ("migration of device"), genital haemorrhage ("excessive bleeding") and pregnancy with contraceptive device ("unwanted pregnancy with essure") in a 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 ineffective "device ineffective".In 2015, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device dislocation (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), pregnancy with contraceptive device (seriousness criterion medically significant), dysmenorrhoea ("severe abnormal menstrual pain"), menstrual disorder ("abnormal menstrual cycle"), back pain ("back pain"), abdominal pain ("abdominal pain"), dyspareunia ("pain during intercourse"), headache ("headaches"), hypersensitivity ("allergic reaction"), mood swings ("mood swings") and fatigue ("fatigue").Last menstrual period and estimated date of delivery were not provided.The patient was treated with surgery (hysterectomy).Essure was removed in 2016.At the time of the report, the pelvic pain, device dislocation, genital haemorrhage, pregnancy with contraceptive device, dysmenorrhoea, menstrual disorder, back pain, abdominal pain, dyspareunia, headache, hypersensitivity, mood swings and fatigue outcome was unknown.The pregnancy outcome was not reported.The reporter considered abdominal pain, back pain, device dislocation, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, hypersensitivity, menstrual disorder, mood swings, pelvic pain and pregnancy with contraceptive device to be related to essure.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental 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: 7431802
• MDR Text Key: 105516266
• Report Number: 2951250-2018-01810
• Device Sequence Number: 1
• Product Code: HHS
• 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: 04/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2018
• 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