MAUDE Adverse Event Report: BAYER HEALTHCARE, LLC ESSURE; TRANSCERVICAL, CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Asthma (1726); Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Dizziness (2194); Myalgia (2238); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Weight Changes (2607)

Event Date 04/03/2008

Event Type  Injury  

Event Description

I got the essure from bayer in 2008 soon after that i was in pain, lost a lot of weight, no vitamins in my body, couldn't even walk, headaches, back pain, hip pain, neck pain.Numbness, asthma, copd, sleep apnea, insomnia, numbness, fibromyalgia.The right side of the essure migrated out.How to get a hysterectomy and essure removed.Memory loss, dizziness, fatigue.I do not believe bayer should be able to do the essure anymore and it should be banned.Bayer should be responsible for their actions.Thank you (b)(6).

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL, CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC
• MDR Report Key: 7556662
• MDR Text Key: 109807076
• Report Number: MW5077560
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 45 YR
• Patient Weight: 66