MAUDE Adverse Event Report: BAYER HEALTHCARE LLC. / CONCEPTUS ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Fatigue (1849); Nausea (1970); Hot Flashes/Flushes (2153); Anxiety (2328); Arthralgia (2355); Numbness (2415); Abdominal Cramps (2543); Abdominal Distention (2601); Weight Changes (2607); No Code Available (3191); Constipation (3274)

Event Date 06/13/2013

Event Type  Injury  

Event Description

Ever since having essure implanted i have had nothing but problems: weight gain, bloating, no sex drive, extreme fatigue, bladder and bowel issues, anxiety, numbness in feet, ibd, cramping, hot flashes, night sweats, joint pain, back pain, nausea, diarrhea, constipation, metallic taste in mouth.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC. / CONCEPTUS
• MDR Report Key: 7769524
• MDR Text Key: 116931109
• Report Number: MW5079007
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• 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: 08/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 50 YR
• Patient Weight: 97