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

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

Patient Problems Abdominal Pain (1685); Inflammation (1932); Pain (1994); Tingling (2171); Cramp(s) (2193); Anxiety (2328); Depression (2361); Numbness (2415); Neck Stiffness (2434); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Weight Changes (2607); Heavier Menses (2666)

Event Date 09/20/2017

Event Type  Injury  

Event Description

Inflammation, pain, and stiffness in all joints.Foggy thoughts causing stupidity.Weight gain, neck, back, and hip pain.Headaches, tooth pain and ear pain.Leg numbness and tingling.Leg, hands, and arm cramps.Heavy periods, stabbing vaginal pain, insomnia from pain.Abdominal pain, anxiety, and depression.All from essure implant in 2013 off and on symptoms.Continues to get worse as time goes by.Made me quit my job of 23 years because i physically can't do it with this pain that randomly plagues me.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7772671
• MDR Text Key: 117003776
• Report Number: MW5079049
• 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: Patient
• Type of Report: Initial
• Report Date: 08/08/2018

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 105