MAUDE Adverse Event Report: ESSURE

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

Patient Problems Headache (1880); Menstrual Irregularities (1959); Pain (1994); Discomfort (2330); Heavier Menses (2666); Constipation (3274)

Event Date 01/29/2014

Event Type  Injury  

Event Description

Essure procedure done (b)(6) 2014, hsg test showed coils expelled/migrated from tubes not quire sure where they are now.Have cramping, lower back pain, headache, pressure in pelvic area which makes it uncomfortable to sit sometimes, pass tissue at times, irregular periods, constipation.

• Brand Name: ESSURE
• Type of Device: ESSURE
• MDR Report Key: 4270869
• MDR Text Key: 20977148
• Report Number: MW5039208
• 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: 11/17/2014

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2014
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 98