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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Myalgia (2238); Abdominal Cramps (2543); Heavier Menses (2666); No Code Available (3191)

Event Date 09/23/2014

Event Type  Injury  

Event Description

I had essure implanted (b)(6) 2014.Within a month i could tell a difference on how i felt mentally.By (b)(6) my periods were heavier, the cramps were 10 times worse than they had ever been.And my body would ache.I am also allergic to metal which informed my ob/gyn before implanting and he responded with, ¿there is not enough metal to affect you." on (b)(6) 2018 i had a total hysterectomy and i can already tell a difference in how i feel both mentally and physically.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 8142093
• MDR Text Key: 129820268
• Report Number: MW5081926
• 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: 12/05/2018

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Weight: 73