MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Insufficient Information (3190)

Patient Problems Autoimmune Disorder (1732); Diarrhea (1811); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Blurred Vision (2137); Myalgia (2238); Weight Changes (2607)

Event Date 09/01/2009

Event Type  Injury  

Event Description

(b)(4).Migraines, brain for, forgetful, blurred vision, diarrhea, autoimmune disease, weight gain, pelvic pain, joint and muscle pain, teeth going bad.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 7215353
• MDR Text Key: 98088203
• Report Number: MW5074825
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/09/2017

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: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: METFORMIN, DIOVAN, ALLPURINOL
• Patient Outcome(s): Required Intervention
• Patient Age: 44.000 YR