MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Pain (1994)

Event Date 05/15/2014

Event Type  Injury  

Event Description

Having severe pelvic pains.Was told one of my coils is missing.Still in pain.No explanation of the pain or anything.(b)(4).

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 3875289
• MDR Text Key: 21494693
• Report Number: MW5036609
• 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: 05/17/2014

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: 06/16/2014
• Patient Sequence Number: 1
• Treatment: ESSURE
• Patient Outcome(s): Other
• Patient Age: 26.000 YR