FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 5107563 · Received September 28, 2015

Report

Report Number
MW5056563
Event Type
Injury
Date Received
September 28, 2015
Date of Event
February 28, 2015
Report Date
September 26, 2015
Manufacturer
BAYER
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

(B)(4). I GOT THE ESSURE PROCEDURE DONE AROUND 7 OR 8 MONTHS LATER I START TO FEEL WEAK CAN NO LONGER WALK , FEVER STARTS COLD SWEATS THEN MY HANDS START TO TURN BLUE /BLK ALONG WITH MY FEET THEN I START HAVING TROUBLE BREATHING. MY RESPIRATORY SYSTEM SHUTS DOWN. I'M UNRESPONSIVE I GET PUT ON LIFE SUPPORT AN INFECTIOUS DISEASE DR PUMPS ME WITH LARGE AMOUNTS OF STEROIDS HE SAVED MY LIFE. I STAYED IN THE HOSPITAL FOR A MONTH I LEFT THERE UNABLE TO WALK DUE TO MUSCLE WEAKNESS IT TOOK ME 4 TO 5 MONTHS TO WALK. I STILL HAD NO ANSWERS DR WAS UNSURE WHAT CAUSE WAS. I WENT TO A RHUMATOID SPECIALIST BECAUSE ONE THING WE KNOW I HAVE RAYNAUDS SYNDROME SHE DIAGNOSED ME WITH A TERMINAL AUTOIMMUNE DISEASE CALLED VASCULITIS. PUT ON METHOTREXATE FOR 4 YRS ONCE A WEEK AND STILL NOT FEELING WELL. I AM SUFFERING FROM FATIGUE PAIN HEADACHES SO MANY OTHER ISSUES. I KNOW HAVE DEVELOPED AN INTOLERANCE TO GLUTEN , WHEAT EGG MILK SOY PEANUTS AND SHRIMP ALONG WITH ALLERGIES TO TOILET PAPER, SHAMPOO DEODORANT AND I KEEP FINDING NEW THINGS AND THE SYMPTOMS ARE WORSE THAN EVER. ALL OF THIS IS DOCUMENTED. I BARELY HEARD ABOUT THIS A FEW DAYS AGO I'M VERY UPSET. I TOO HAVE A NICKEL METAL ALLERGY EVER SINCE I WAS A LITTLE GIRL. I WAS NOT TESTED BEFORE THE PROCEDURE WAS DONE. I NEED TO GET THESE COILS OUT. WHATEVER I HAVE TO LOOSE. OR I'M AFRAID I WILL HAVE ANOTHER LIFE THREATENING EVENT

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
638178 ESSURE HHS BAYER

Patients

Seq Age Sex Outcome Treatment
1 42.000 YR Hospitalization| L NOTHING