MAUDE Adverse Event Report: BAYER ESSURE

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

Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Muscle Spasm(s) (1966); Pain (1994); Skin Irritation (2076); Vertigo (2134); Blurred Vision (2137); Cramp(s) (2193); Arthralgia (2355); Abdominal Distention (2601); Weight Changes (2607)

Event Date 08/05/2014

Event Type  Injury  

Event Description

(b)(4).I have constant skin problems, bloating, cramps, weird bleeding, headaches, vertigo, joint pain, muscle spasms, painful sex, blurred vision, tooth pain and weight gain.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 6440483
• MDR Text Key: 71092555
• Report Number: MW5068713
• Device Sequence Number: 1
• Product Code: HHA
• 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: 03/28/2017

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: 03/28/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31.000 YR