FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 4891993 · Received July 6, 2015

Report

Report Number
MW5043489
Event Type
Injury
Date Received
July 6, 2015
Date of Event
May 18, 2015
Report Date
November 17, 2014
Manufacturer
BAYER
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

(B)(4). CHRONIC EXCRUCIATING PAIN ON LEFT SIDE, EXCRUCIATING MENSTRUAL CYCLES, HEAVY BLEEDING AND CLOTTING, NIGHT SWEATS, INSOMNIA, VOMITING, UNABLE TO WORK AND CARE FOR MY FAMILY REGULARLY, MIGRAINES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
436525 ESSURE HHS BAYER

Patients

Seq Age Sex Outcome Treatment
1 39.000 YR