MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Pain (1994)

Event Date 03/24/2017

Event Type  Injury  

Event Description

(b)(4).Due to chronic pelvic pain, i made an apt with my obgyn.Found out that the essure coil in my left fallopian tube had broken apart and will need major surgery to remove it.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 6463536
• MDR Text Key: 71880692
• Report Number: MW5068946
• 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: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 39.000 YR