MAUDE Adverse Event Report: CONCEPTUS, INC. ESSURE PERMANENT BIRTH CONTROL SYSTEM

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

Patient Problem Pain (1994)

Event Date 12/01/2017

Event Type  Injury  

Event Description

Pt was having mri lower extremity on ge 1.5 closed unit.Pt had already disclosed info regarding implanted essure device.Safety info for the device had been verified.After only scout series the pt reported pain in the pelvic area.The tech removed the pt from the scan room and the procedure was ended.

• Brand Name: ESSURE PERMANENT BIRTH CONTROL SYSTEM
• Type of Device: PERMANENT BIRTH CONTROL
• Manufacturer (Section D): CONCEPTUS, INC.; san carlos CA 94070
• MDR Report Key: 7086727
• MDR Text Key: 94108246
• Report Number: MW5073756
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR