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

Model Number ESS305

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Hair Loss (1877); Tinnitus (2103); Tingling (2171); Cramp(s) (2193); Urinary Frequency (2275); Arthralgia (2355)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 31-aug-2017.This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain lower ("cramp") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: consumer cannot stand fake earrings.Concurrent conditions included rheumatic disorder, thyroid disorder and nickel sensitivity.In 2010, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), paraesthesia ("tingling in pelvis"), arthralgia ("joint pain/ pain in fingers/wrists/hip"), abdominal pain ("abdominal pain"), tinnitus ("tinnitus"), pollakiuria ("urinating a lot"), weight increased ("weight gain"), pain of skin ("painful head skin") and alopecia ("hair loss").The patient was treated with surgery (has an appointment for removal of essure on (b)(6) 2016).At the time of the report, the abdominal pain lower, paraesthesia, arthralgia, abdominal pain, tinnitus, pollakiuria, weight increased, pain of skin and alopecia outcome was unknown.The reporter provided no causality assessment for abdominal pain, abdominal pain lower, alopecia, arthralgia, pain of skin, paraesthesia, pollakiuria, tinnitus and weight increased with essure.The reporter commented: essure insertion went smoothly.She did not do an official allergy test.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 04-sep-2017 for the following meddra preferred term: abdominal pain lower.The analysis in the global safety database revealed 465 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.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: 6896897
• MDR Text Key: 87464997
• Report Number: 2951250-2017-04032
• 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: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• 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
• Date Manufacturer Received: 08/31/2017
• 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