MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Complaint, Ill-Defined (2331); Heavier Menses (2666)

Event Date 09/04/2014

Event Type  Injury  

Event Description

(b)(4).Starting having irregular heavy bleeding.A week later i passed 2 pieces of light pink tissue.The bleeding came back.And didn't stop for twenty days.Has been irregular since.Right pelvic pain.Painful sex, bleeding after sex.Memory problems.Ultrasound couldn't see my coil on the right.I had an mri of my c-spine aug 21st (unrelated injury) and can't help but wonder if it dislodged my right coil.I an scheduled for further testing too find the coil.If in my uterine cavity i will have to have a hysterectomy! not in my plans!!.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4361657
• MDR Text Key: 5232771
• Report Number: MW5039764
• 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: 11/15/2014

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: 12/24/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 44.000 YR