MAUDE Adverse Event Report: CONCEPTUS ESSURE

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Patient Problems Emotional Changes (1831); Fatigue (1849); Headache (1880); Pain (1994); Arthralgia (2355); Irritability (2421); Abdominal Cramps (2543); Heavier Menses (2666)

Event Date 11/23/2013

Event Type  Injury  

Event Description

I have had extremely bad body aches and joint pain, headaches,heavy bleeding when on my menstrual cycle and cramping which is not normal for me.I am very fatigued and moody with is unlike me.I had to have essure placed twice on my left side tube because one was lost.The coil was no where to be found.The first placement was on (b)(6) 2013 and the second was in (b)(6) 2013.

• Brand Name: ESSURE
• Manufacturer (Section D): CONCEPTUS
• MDR Report Key: 3627143
• MDR Text Key: 4133293
• Report Number: MW5034401
• 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: 02/03/2014

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: 02/13/2014
• Patient Sequence Number: 1
• Patient Age: 40.000 YR