FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 4883659 · Received June 25, 2015

Report

Report Number
MW5043371
Event Type
Injury
Date Received
June 25, 2015
Date of Event
June 28, 2015
Report Date
June 25, 2015
Manufacturer
BATYER
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD THE ESSURE PUT IN, IN 2010. I HAVE VERY SEVERE PAINS WHEN I'M ABOUT TO START MY PERIOD AND WHILE ON MY PERIOD. I'VE NOTICED IF I MOVE CERTAIN WAYS IT WILL PUNCH OR FEEL LIKE A STABBING PAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
410801 ESSURE ESSURE HHS BATYER

Patients

Seq Age Sex Outcome Treatment
1 26 YR Required Intervention