FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 3687385 · Received March 19, 2014

Report

Report Number
MW5034963
Event Type
Injury
Date Received
March 19, 2014
Date of Event
July 10, 2013
Report Date
February 18, 2014
Manufacturer
CONCEPTUS
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

I HAVE ALWAYS HAD A REGULAR PREDICTABLE CYCLE. TWO NORMAL PREGNANCIES AND DELIVERIES. I HAVE HAD NO MAJOR HEALTH PROBLEMS. MY DR SOLD ME ON ESSURE. DEVICE PLACEMENT IN (B)(6) OF 2013 WENT AS EXPECTED. CAME HOME GROGGY FROM DR'S OFFICE. FELT BAD PERIOD CRAMPS WITHIN THE HR AND HAD LIGHT SPOTTING. LIGHT SPOTTING RESIDED WITHIN A FEW DAYS AND AFTER A WEEK OR SO THE CRAMPING REDUCED TO A 2/10 PAIN SCALE. OVER THE NEXT 6 MONTHS OF MY BUSY LIFE WITH TWO CHILDREN AND HOLIDAYS I DEALT WITH THE 2-4/10 CRAMPING/BURNING IN MY PELVIC AREA. IT ALMOST FELT LIKE A BLADDER INFECTION BUT AS A NURSE I COULD LOOK AT MY URINE AND TELL THAT IT WAS NOT. STRANGELY I COULD FEEL THIS PAIN IN TWO ISOLATED AREAS. ONE HIGH IN THE LLQ AND ONE LOW IN MY RLQ. IMMEDIATELY AFTER THE HOLIDAYS I WAS ABLE TO HAVE MY HSG WHICH SHOWED THE RIGHT COIL TO BE IN MY PELVIC FLOOR. AT THE TIME I WAS ALSO BEING WORKED UP TO HAVE MY GALLBLADDER REMOVED HAVING HAD CHRONIC PAIN FOR 3+ WEEKS THAT RELATED TO FOOD AND POLYPS WERE FOUND. SURG WAS ON (B)(6) 2014- L COIL AND TUBE REMOVED. 2 STABLES AND A SMALL "MILLIMETERS" OF THE COIL REMAINS. THE R COIL TOOK HER 1.5 HRS TO FIND. THE COIL WAS FOUND , USING X-RAY, BETWEEN MY PELVIC WALL AND MY R OVARY. THE OVARY AND PELVIC WALL, AFTER BEING RUBBED RAW, HAD ADHERED TOGETHER. IT TOOK HER OVER AN HR TO REMOVE THIS COIL BECAUSE THEY STRETCH AND FRAGMENT. I'M 3 WEEKS POST OP. MY WOUNDS HAVE HEALED BUT I HURT WORSE THAN BEFORE THE SURGERY. I HAVEN'T BEEN ABLE TO PICK UP MY (B)(6) IN 3 WEEKS. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
163068 ESSURE HHS CONCEPTUS

Patients

Seq Age Sex Outcome Treatment
1 30.000 YR Hospitalization| O| S MULTI V.