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

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hearing Loss (1882); Hypersensitivity/Allergic reaction (1907); Tinnitus (2103); Fasciitis (2375); Vascular System (Circulation), Impaired (2572)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of allergy to metals ("hypersensitivity to the three metals that make up the essure inserts") and deafness ("ent problems: i lost more than half of my hearing and gained terrible tinnitus ") in a female patient who had essure inserted for sterilisation.The occurrence of additional non-serious events is detailed below.In 2012, the patient had essure inserted.On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required), deafness (seriousness criterion medically significant), tinnitus ("ent problems: i lost more than half of my hearing and gained terrible tinnitus "), plantar fasciitis ("fasciitis, one on each foot"), cardiovascular disorder ("disturbances of circulation, intestinal transit") and gastrointestinal disorder ("disturbances of circulation, intestinal transit").The patient will be treated with surgery (removal of the inserts is scheduled for september).Essure treatment was not changed.At the time of the report, the allergy to metals, deafness, tinnitus, plantar fasciitis, cardiovascular disorder and gastrointestinal disorder outcome was unknown.The reporter considered allergy to metals, cardiovascular disorder, deafness, gastrointestinal disorder, plantar fasciitis and tinnitus 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: allergy to metals.The analysis in the global safety database revealed 266 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: 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: 6728216
• MDR Text Key: 80552994
• Report Number: 2951250-2017-02560
• 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,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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 07/20/2017
• 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