MAUDE Adverse Event Report: BAYER HEALTHCARE, LLC ESSURE; TRANSCERVIUCAL CONTARCEPTIVE TUBAL OCCLUSION DEVICE

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

Patient Problems Emotional Changes (1831); Hypersensitivity/Allergic reaction (1907); Pain (1994); Cramp(s) (2193); Weight Changes (2607)

Event Date 01/20/2018

Event Type  malfunction  

Event Description

Essure springs implanted (b)(6) 2013 weight and mood changes, along with being allergic to nickel.Heavy cramping and pain mainly on the left side of my ovaries.Fda safety report id # (b)(4).

• Brand Name: ESSURE
• Type of Device: TRANSCERVIUCAL CONTARCEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC
• MDR Report Key: 9496479
• MDR Text Key: 172430446
• Report Number: MW5091772
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR