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); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Miscarriage (1962); Pain (1994); Rash (2033); Weight Changes (2607); Heavier Menses (2666); Pregnancy (3193)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('stabbing pain'), pregnancy with contraceptive device ('pregnant') and abortion spontaneous ('miscarriage') in an adult 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".Medical conditions: essure confirmation test: bilateral occlusion.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abortion spontaneous (seriousness criterion medically significant), dysmenorrhoea ("dysmenorrhea (cramping)"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), allergy to metals ("nickel allergy"), psychological trauma ("psych injury"), fatigue ("fatigue"), headache ("headaches"), migraine ("migraine"), alopecia ("hair loss"), abdominal pain ("severe cramping") and rash ("rash"), was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and was found to have weight increased ("weight gain").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2013.At the time of the report, the pelvic pain, pregnancy with contraceptive device, abortion spontaneous, dysmenorrhoea, menorrhagia, allergy to metals, psychological trauma, weight increased, fatigue, headache, migraine, alopecia, abdominal pain and rash outcome was unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abdominal pain, abortion spontaneous, allergy to metals, alopecia, dysmenorrhoea, fatigue, headache, menorrhagia, migraine, pelvic pain, pregnancy with contraceptive device, psychological trauma, rash and weight increased to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-aug-2019: plaintiff fact sheet was received and the following information was received: patient¿s date of birth added; essure was inserted on (b)(6) 2008 and removed on (b)(6) 2013; the event injury was specified as dysmenorrhea (cramping), weight gain, fatigue, headaches, migraine, hair loss, severe cramping, rash, menorrhagia (heavy menstrual bleeding), nickel allergy, psych injury, stabbing pain, pregnant, miscarried and device ineffective.The case will be deleted from bayer pv database.Nullification reason: as per follow-up information received, this case was identified as a duplicate of case (b)(4).All the information from case (b)(4) has been transferred to case (b)(4).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: 8963783
• MDR Text Key: 161193150
• Report Number: 2951250-2019-05405
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• 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: 08/28/2019
• 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