MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Device Or Device Fragments Location Unknown (2590); Malposition of Device (2616)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Hair Loss (1877); Headache (1880); Depression (2361); Weight Changes (2607)

Event Date 06/05/2013

Event Type  Injury  

Event Description

(b)(4).Mis placed coil (out of place and not ever found).Depression.Bloated stomach.Weight gain.Hair loss.Loss of appetite.Severe headaches.Fatigue.Severe abdominal pain.Lots of visits to the e.R.Lots of xrays, ultrasounds etc.This product has kept me down for 2 years now.I am finally removing tubes and coils.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4585179
• MDR Text Key: 15126037
• Report Number: MW5041345
• 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
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/09/2015

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: Other
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 30.000 YR