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); Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Tinnitus (2103); Burning Sensation (2146); Dizziness (2194)

Event Date 10/20/2013

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 24-jul-2017.This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain ("abdominal pain") in a (b)(6) female patient who had essure (batch no.B21673) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, 1 month 7 days after insertion of essure, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), headache ("headaches"), musculoskeletal pain ("joint pain/muscle pain"), dysmenorrhoea ("very painful menstrual periods"), vulvovaginal pain ("vaginal pain"), back pain ("back ache"), skin burning sensation ("burning sensation on skin of face, body and hands"), fatigue ("constant fatigue"), tinnitus ("tinnitus"), dizziness ("dizzy spells") and memory impairment ("memory lapses").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2017.At the time of the report, the abdominal pain, headache, musculoskeletal pain, dysmenorrhoea, vulvovaginal pain, back pain, skin burning sensation, fatigue, tinnitus, dizziness and memory impairment outcome was unknown.The reporter provided no causality assessment for abdominal pain, back pain, dizziness, dysmenorrhoea, fatigue, headache, memory impairment, musculoskeletal pain, skin burning sensation, tinnitus and vulvovaginal pain with essure.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was (b)(6).The list of device similar events contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on 25-jul-2017 for the following meddra preferred term: abdominal pain.The analysis in the global safety database revealed 1084 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Further company follow-up with the regulatory authority is not possible.Incident.At the time of reporting, 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.

Manufacturer Narrative

This case was initially received via regulatory authority ansm (reference number: (b)(4)) on 24-jul-2017.The most recent information was received on 09-aug-2017.This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain ("abdominal pain") in a (b)(6) year-old female patient who had essure (batch no.B21673 (invalid)) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, 1 month 7 days after insertion of essure, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), headache ("headaches"), musculoskeletal pain ("joint pain/muscle pain"), dysmenorrhoea ("very painful menstrual periods"), vulvovaginal pain ("vaginal pain"), back pain ("back ache"), skin burning sensation ("burning sensation on skin of face, body and hands"), fatigue ("constant fatigue"), tinnitus ("tinnitus"), dizziness ("dizzy spells") and memory impairment ("memory lapses").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2017.At the time of the report, the abdominal pain, headache, musculoskeletal pain, dysmenorrhoea, vulvovaginal pain, back pain, skin burning sensation, fatigue, tinnitus, dizziness and memory impairment outcome was unknown.The reporter provided no causality assessment for abdominal pain, back pain, dizziness, dysmenorrhoea, fatigue, headache, memory impairment, musculoskeletal pain, skin burning sensation, tinnitus and vulvovaginal pain with essure.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be (b)(6).The list of device similar events contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on 09-aug-2017 for the following meddra preferred term: abdominal pain.The analysis in the global safety database revealed 1.109 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 9-aug-2017: quality-safety evaluation of ptc.Incident: no valid 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 07981-0915
• MDR Report Key: 6770713
• MDR Text Key: 81937581
• Report Number: 2951250-2017-02743
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ESS305
• Device Lot Number: B21673(INVALID)
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2017
• 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 Age: 46 YR
• Patient Weight: 76