FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 4251111 · Received November 5, 2014

Report

Report Number
MW5039001
Event Type
Injury
Date Received
November 5, 2014
Date of Event
January 4, 2010
Report Date
November 5, 2014
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD THE ESSURE AND STARTING EXPERIENCING HORRIBLE ABDOMINAL PAINS, AFTER A COUPLE MONTHS. I HAD GONE BACK IN TO SEE MY OB/GYN AND THE IMPLANTS HAD ACTUALLY MIGRATED AND I NEEDED TO HAVE SURGERY TO REMOVE THEM AND MY TUBES REMOVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
710532 ESSURE ESSURE HHS 761616/774372

Patients

Seq Age Sex Outcome Treatment
1 34 YR Hospitalization| R