MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Gastritis (1874); Headache (1880); Irritation (1941); Tinnitus (2103); Blurred Vision (2137); Malaise (2359)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of hysterectomy ("hysterectomy") in a (b)(6) female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Medical conditions: not allergic to nickel, chrome or cobalt.In (b)(6) 2013, the patient had essure inserted.In (b)(6) 2014, 1 month after insertion of essure, the patient experienced ear disorder ("ent symptoms"), nasal disorder ("ent symptoms") and throat irritation ("ent symptoms").In (b)(6) 2014, the patient experienced menopause ("menopause at (b)(6)") with hormone level abnormal.In (b)(6) 2017, the patient underwent hysterectomy (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced malaise ("feeling bad"), headache ("violent headaches"), tendonitis ("recurrent tendonitis"), disturbance in attention ("difficulty concentrating"), vision blurred ("blurred vision"), tinnitus ("tinnitus"), fatigue ("crushing fatigue"), gastritis ("problems with inflammation of the stomach, oesophagus, colon, sinuses"), oesophagitis ("problems with inflammation of the stomach, oesophagus, colon, sinuses"), colitis ("problems with inflammation of the stomach, oesophagus, colon, sinuses") and sinusitis ("problems with inflammation of the stomach, oesophagus, colon, sinuses").Essure was removed in (b)(6) 2017.At the time of the report, the hysterectomy outcome was unknown and the malaise, headache, ear disorder, nasal disorder, throat irritation, menopause, tendonitis, disturbance in attention, vision blurred, tinnitus, fatigue, gastritis, oesophagitis, colitis and sinusitis was resolving.The reporter considered colitis, disturbance in attention, ear disorder, fatigue, gastritis, headache, hysterectomy, malaise, menopause, nasal disorder, oesophagitis, sinusitis, tendonitis, throat irritation, tinnitus and vision blurred to be related to essure.The reporter commented an article on a blog.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 12-jul-2017 for the following meddra preferred term: medical device removal.The analysis in the global safety database revealed 115 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 is not possible.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: INSERT, TUBAL OCCLUSION
• 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: 6727509
• MDR Text Key: 80512222
• Report Number: 2951250-2017-02577
• 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: foreign,other
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 38 YR