MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Abdominal Cramps (2543); Heavier Menses (2666); No Information (3190)

Event Date 06/25/2014

Event Type  Injury  

Event Description

(b)(4).Intense cramps, heavy bleeding, severe right sides lower abdomen pain.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5010925
• MDR Text Key: 23325535
• Report Number: MW5055451
• Device Sequence Number: 0
• Product Code: HHS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Remedial Action: Other
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 24.000 YR