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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Pain (1994); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') and leukopenia ('leukopenia') in a female patient who had essure (batch no.627282) inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included ascorbic acid, atomoxetine, cholecalciferol (vitamin d 3), iron and vitamin b12 nos (vitamin b 12).On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), leukopenia (seriousness criterion medically significant), genital haemorrhage ("excessive bleeding"), fibromyalgia ("i developed adenomyosis"), anaemia ("anemia"), feeling abnormal ("i experienced extreme brain fog"), adenomyosis ("adenomyosis") and gastrooesophageal reflux disease ("acid reflux").The patient was treated with surgery (medical device removal).At the time of the report, the pelvic pain, leukopenia, genital haemorrhage, fibromyalgia, anaemia, feeling abnormal and adenomyosis outcome was unknown and the gastrooesophageal reflux disease had resolved.The reporter provided no causality assessment for adenomyosis, anaemia, feeling abnormal, fibromyalgia, genital haemorrhage, leukopenia and pelvic pain with essure.The reporter considered gastrooesophageal reflux disease to be related to essure.The reporter commented: hysterectomy surgery scheduled for 2019, hospitalization, disability/ permanent damage and required intervention is listed in the event outcome section, however not specified and /or assigned to one of the events.Lot number: 627282, manufacture date: 2008-05, expiration date: 2010-05.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: social media report received.Reporter added.Added event acid reflux.Updated events pelvic pain a to serious and genital haemorrhage as non serious.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this 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
• 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: 10017013
• MDR Text Key: 190131159
• Report Number: 2951250-2020-06404
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2020

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 Expiration Date: 05/01/2010
• Device Model Number: ESS305
• Device Lot Number: 627282
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 05/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2008
• 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