MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Migration or Expulsion of Device (1395); Occlusion Within Device (1423)

Patient Problems Fatigue (1849); Pain (1994); Cramp(s) (2193)

Event Date 02/01/2009

Event Type  Injury  

Event Description

(b)(4).This product was inserted by a previous doctor.Serious pain while being inserted.Caused severe cramping, lowered sex drive, leg cramps, overall fatigue.Even though the 6 week test came back positive for occlusion, the coil migrated and embedded into my uterus.I had a hysterectomy to get rid of it and ongoing issues.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5254258
• MDR Text Key: 32293958
• Report Number: MW5058172
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2015

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: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PROZAC
• Patient Outcome(s): Other; Required Intervention