MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Material Fragmentation (1261)

Patient Problems Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958)

Event Date 12/01/2011

Event Type  Injury  

Event Description

(b)(4).Device was implanted (b)(6) 2011.I expelled a partial fragment of the coil in (b)(6) 2011.I had my die test to confirm blockage in (b)(6) 2012.My left side was completely blocked and my right side only partial blocked due to part of the coil being expelled from my body.After years of headaches, memory loss, fatigue, and severe hives on my chest and face it has now been confirmed through a metal allergy blood test that i am highly reactive to nickle, cobalt and titanium.I have removal of my ovaries and tubes scheduled next week on (b)(6) 2016.I cannot wait to get even a fragment of my normal life back!!!.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5455141
• MDR Text Key: 38853464
• Report Number: MW5060434
• 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: 02/15/2016

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 33.000 YR