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

Model Number ESS305

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Autoimmune Disorder (1732); Autoimmune Reaction (1733)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of autoimmune disorder ("autoimmune issues") in a female patient who had essure inserted.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced autoimmune disorder (seriousness criteria medically significant and intervention required).Essure was removed.At the time of the report, the autoimmune disorder had not resolved.The reporter considered autoimmune disorder to be related to essure.Concerning the injuries reported in this case, the following one/ones were reported via social media; autoimmune disease.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.

Manufacturer Narrative

The spontaneous case was reported by a lawyer and describes the occurrence of autoimmune disorder ("autoimmune issues") in a female patient who had essure inserted.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced autoimmune disorder (seriousness criteria medically significant and intervention required).Essure was removed.At the time of the report, the autoimmune disorder had not resolved.The reporter considered autoimmune disorder to be related to essure.Concerning the injuries reported in this case, the following one/ones were reported via social media; autoimmune disease.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-oct-2018: quality safety evaluation of ptc.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of autoimmune disorder ('autoimmune issues') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patients had essure inserted.On an unknown date, the patients experienced autoimmune disorder (seriousness criteria medically significant and intervention required) and allergy to metals ("nickel allergy").Essure was removed.At the time of the report, the autoimmune disorder had not resolved and the allergy to metals outcome was unknown.The reporter considered allergy to metals and autoimmune disorder to be related to essure.Concerning the injuries reported in this case, the following one/ones were reported via social media; autoimmune disease.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-dec-2019: social media received.Event : nickel allergy were added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of autoimmune disorder ('autoimmune issues') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patients had essure inserted.On an unknown date, the patients experienced autoimmune disorder (seriousness criteria medically significant and intervention required) and allergy to metals ("nickel allergy").Essure was removed.At the time of the report, the autoimmune disorder had not resolved and the allergy to metals outcome was unknown.The reporter considered allergy to metals and autoimmune disorder to be related to essure.Concerning the injuries reported in this case, the following one/ones were reported via social media; autoimmune disease.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-jul-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7640606
• MDR Text Key: 112429082
• Report Number: 2951250-2018-02829
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/25/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 10/30/2018; 12/17/2019; 07/23/2020
• Supplement Dates FDA Received: 10/30/2018; 01/07/2020; 07/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention