MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Fatigue (1849); Flatus (1865); Hair Loss (1877); Headache (1880); Menstrual Irregularities (1959); Rash (2033); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666); Constipation (3274)

Event Date 05/16/2012

Event Type  Injury  

Event Description

(b)(4).Since having this device, i have had severe abdominal cramping (mostly on left side).Extreme bloating, unexplained weight gain, severe headaches almost daily, migraines about once a month, rash on torso and thighs, digestive issues including rapid digestion, constipation, diarrhea, and stomach aches even after eating mild foods.I have also had a tooth fracture (never had any issues with teeth beforehand).Hair loss, absence of menstrual periods, only had about 6 periods in the 7 years i've had device.Very painful when i do have them, i'm usually bedridden for the first 3 days with cramps and pain.Heavy bleeding with large clots.Extreme fatigue 3 or 4 days a week, despite getting plenty of rest.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 6886145
• MDR Text Key: 87050552
• Report Number: MW5072306
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38.000 YR