MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Insufficient Information (3190)

Patient Problems Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Pain (1994); Swelling (2091); Tinnitus (2103); Numbness (2415)

Event Date 01/02/2017

Event Type  Injury  

Event Description

(b)(4).Excruciating lower back pain, tingling and swelling in arms and feet, hair loss, memory loss, heavy period, ringing ear, numbness, dry mouth, allergic reaction.Device was paid for by insurance at the time.I'm no longer covered u see that insurance.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 6890777
• MDR Text Key: 87231022
• Report Number: MW5072407
• 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: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41.000 YR