MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Abdominal Pain (1685); Pain (1994)

Event Date 12/31/2014

Event Type  Injury  

Event Description

(b)(4).Abdominal pain radiating to bottom rib front and back.Left essure coil is missing.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4662444
• MDR Text Key: 5609275
• Report Number: MW5041846
• 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: 03/29/2015

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: 04/06/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48.000 YR