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

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Visual Impairment (2138); Myalgia (2238)

Event Date 09/22/2017

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on 05-jan-2018.The most recent information was received on 16-oct-2019.This spontaneous case was reported by a consumer and describes the occurrence of allergy to metals ('nickel allergy') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On (b)(6) 2017, the patient experienced allergy to metals (seriousness criterion medically significant), visual impairment ("vision disorder"), myalgia ("muscular pain") and amnesia ("multiple loss of memory").At the time of the report, the allergy to metals, visual impairment, myalgia and amnesia outcome was unknown.The reporter provided no causality assessment for allergy to metals, amnesia, myalgia and visual impairment with essure.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on 08-jan-2018 for the following meddra preferred term: allergy to metals: the analysis in the global safety database revealed 357 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.Most recent follow-up information incorporated above includes: on 16-oct-2019: 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).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: 9217256
• MDR Text Key: 176394239
• Report Number: 2951250-2019-10627
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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
• Report Date: 10/22/2019

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
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 10/22/2019
• 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