MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Nausea (1970); Pain (1994); Cramp(s) (2193)

Event Date 08/01/2013

Event Type  Injury  

Event Description

(b)(4).The initial placement of the device caused extreme pain and nausea.The procedure and recovery lasted well over an hour.Follow up hsg after 4 months showed one tube occluded and the second essure coil was gone.The coil in place is on the left side.I experience extreme pain on the left side during ovulation and the pain/cramping during my periods has become severe.Before essure i experienced no pain during ovulation and my periods were not painful.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4965276
• MDR Text Key: 6196407
• Report Number: MW5045058
• 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: 07/01/2015

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: 08/04/2015
• Patient Sequence Number: 1
• Treatment: ZOLOFT
• Patient Outcome(s): Other
• Patient Age: 35.000 YR