FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 3913197 · Received June 27, 2014

Report

Report Number
MW5037023
Event Type
Injury
Date Received
June 27, 2014
Date of Event
June 22, 2014
Report Date
June 26, 2014
Manufacturer
BAYER
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

LAST YEAR AROUND THIS TIME, ((B)(6)) I HAD MY SECOND CHILD. I TOLD MY DR THAT I WANTED A TUBAL LIGATION. I NEVER CHOSE THE TYPE OF PROCEDURE I WANTED. THEY JUST KIND OF GAVE IT TO ME. SO I HAD MY CHILD VIA C-SECTION AND THEY IMPLANTED ESSURE RIGHT AFTER I HAD GIVEN BIRTH. DURING THE C-SECTION, I KEEP TELLING THE DR THAT I FELT PAIN AND NOT PRESSURE. MY RIGHT SIDE WAS NOT COMPLETELY NUMB AS MY LEFT, PRIOR TO THE SURGERY. SO SHE UPPED THE DOSAGE UNTIL LATER SHE SAID SHE COULDN'T GIVE ME ANYMORE. FAST FORWARDING UNTIL NOW, EVERY MONTH, EITHER BEFORE OR DURING MY MENSTRUAL CYCLE, I WOULD HAVE THESE SHARP, STABBING, CONSTANT, AND INTERMITTENT PAINS ON THAT SAME RIGHT SIDE, IN THE SAME EXACT SPOT. LAST MONTH, MY MENSTRUAL CYCLE CAME ON TWICE WITH EVEN STRONGER PAINS IN THAT VERY SAME SPOT. THIS PAST MONDAY, I WAS IN EXTREME PAIN AND THE NEXT DAY, I WENT TO SEE AN URGENT CARE DR WHO HAD TO INFORM ME, AFTER A PELVIC EXAM, THAT I HAD A MASSIVE CYST ON MY RIGHT OVARY THAT BLED OUT. SINCE THE EXAM, THAT VERY SPOT HAS SINCE STILL BEEN VERY PAINFUL AND SORE TO THE TOUCH. TO ADD SOME MORE DETAILS: I HAD ANOTHER C-SECTION 3 YRS PRIOR TO THE BIRTH OF MY SECOND CHILD WITHOUT ANY PROBLEMS AND THAT PREGNANCY WAS A TWIN PREGNANCY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
376050 ESSURE ESSURE HHS BAYER

Patients

Seq Age Sex Outcome Treatment
1 23 YR