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

Model Number ESS305

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Menstrual Irregularities (1959); Pain (1994); Discomfort (2330); Fungal Infection (2419); Confusion/ Disorientation (2553); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('one of the devices was noted to have migrated and was found in the wall of the uterus') and autoimmune disorder ('there are so many autoimmune') in an adult female patient who had essure (batch no.B06102) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), device expulsion ("one of the devices was noted to have migrated and was found in the wall of the uterus"), pelvic pain ("pain/ prolonged and excessive pain"), feeling abnormal ("brain fog"), fatigue ("constant tiredness and fatigue"), candida infection ("recurrent thrush infections"), dysmenorrhoea ("painful periods"), menorrhagia ("heavy periods") and pelvic discomfort ("discomfort").The patient was treated with surgery (laparoscopic hysterectomy).Essure was removed in (b)(6) 2019.At the time of the report, the embedded device, autoimmune disorder, device expulsion, pelvic pain, feeling abnormal, fatigue, candida infection, dysmenorrhoea, menorrhagia and pelvic discomfort outcome was unknown.The reporter considered autoimmune disorder, candida infection, device expulsion, dysmenorrhoea, embedded device, fatigue, feeling abnormal, menorrhagia, pelvic discomfort and pelvic pain to be related to essure."concerning the injuries reported in this case, the following one/ones was/were reported via social media: autoimmune disorder".Most recent follow-up information incorporated above includes: on 30-jul-2019: this case was processed with wrong wucin and should be deleted from bayer database.New case (2019-149064) was created and all information was transferred.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: 8884236
• MDR Text Key: 154003527
• Report Number: 2951250-2019-04676
• 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: 08/12/2019

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
• Device Lot Number: B06102
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/12/2019
• 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