MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590)

Patient Problems Tissue Damage (2104); Urinary Tract Infection (2120); Disability (2371)

Event Date 07/01/2010

Event Type  Other  

Event Description

Caller reports having essure implanted in 2010, one year later she was forced to have a full hysterectomy.Caller states she had a history of fibroids but once the essure was implanted the tumors grew and proliferated causing her to have a hysterectomy.Caller reports a year ago she contracted a bladder infection.It was found that one of the essure coils was not removed and has migrated to an unknown location in the caller's body.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4905800
• MDR Text Key: 6020515
• Report Number: MW5043930
• Device Sequence Number: 1
• Product Code: HHS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 07/08/2015
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 91