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 Autoimmune Disorder (1732); Pain (1994); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain") and multiple sclerosis ("autoimmune-like symptoms, other (ms)") in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included bleeding genital, dyspareunia, bladder pain, cystitis interstitial, nausea, dizziness, anxiety, depression, gerd, constipation, dry mouth, asthma, smoker, vulvodynia and leg pain.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), multiple sclerosis (seriousness criterion medically significant) and urinary tract disorder ("urinary problems").The patient was treated with surgery (laparoscopic bilateral salpingectomy and removal of essure devices bilaterally).Essure was removed on (b)(6) 2011.At the time of the report, the pelvic pain, multiple sclerosis and urinary tract disorder outcome was unknown.The reporter considered multiple sclerosis, pelvic pain and urinary tract disorder to be related to essure.The reporter commented: the absence of the essure coils that were present in the 2010 images, there doesn¿t seem to be a significant change in position of the lead.May be on insertion a slight deviation towards the ilium, which may be slightly flattened.

• 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: 8225728
• MDR Text Key: 132340408
• Report Number: 2951250-2019-00218
• 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: 01/08/2019

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
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/08/2019
• 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