MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Loose or Intermittent Connection (1371); Insufficient Information (3190)

Patient Problems Fatigue (1849); Nausea (1970); Pain (1994); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 08/04/2015

Event Type  Injury  

Event Description

(b)(4).My monthly have been so bad i have missed work and its hard to take care of my son.When it that time of the month i feel like i have no energy.I get pale, feel nauseated, pain in my pelvic area, hips and back.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5018512
• MDR Text Key: 23594844
• Report Number: MW5055572
• 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
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 28.000 YR