MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Hair Loss (1877); Headache (1880); Pain (1994); Rash (2033); Thyroid Problems (2102); Discomfort (2330); Sleep Dysfunction (2517); Weight Changes (2607); Heavier Menses (2666)

Event Date 07/24/2013

Event Type  Injury  

Event Description

(b)(4) on this day i begin having heavy cycles that have continued the past two years lower back pain, lower abdominal pain, headaches, rash on my left arm, vaginal discomfort, discomfort during and after intercourse, pressure on my lower left side, frequently getting sick, thyroid disease, weight gain, pain in my legs, hair loss, and insomnia.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4582794
• MDR Text Key: 5481894
• Report Number: MW5041308
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: NOTHING
• Patient Outcome(s): Other
• Patient Age: 26.000 YR