ESSURE

Report

• Report Number: MW5057761
• Event Type: Injury
• Date Received: November 9, 2015
• Date of Event: September 9, 2015
• Report Date: November 5, 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 HAD ESSURE IMPLANTED AFTER THE BIRTH OF MY DAUGHTER (B)(6) AGO. I HAVE STARTED TO EXPERIENCE HAIR LOSS, CRAMPING CONSTANTLY, BLEEDING IRREGULARLY, AND SHARP PAINS IN MY ABDOMEN. I WENT BACK AND FOURTH WITH MY DOCTOR. THEY TOOK ULTRASOUNDS TO SEE IF THEY COULD SEE ANYTHING. SHE ASKED IF I HAD AN IUD IMPLANTED. I SAID NO I HAVE ESSURE. WELL THE DOCTOR ENDED UP LOOKING AT IT AND WE HAD TO REMOVE THE COIL FROM ONE OF THE TUBES. IT WAS POKING ME AND THAT IS WHAT WAS CAUSING THE SHARP PAINS. I MISSED WORK AND TIME AWAY FROM MY KIDS BECAUSE I WAS DOWN. THIS TIME OF EVENTS LASTED ABOUT 4 WEEKS IN TOTAL. IT WAS HORRIBLE AND HAS BEEN A HORRIBLE EXPERIENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
741735	ESSURE		HHS	BAYER

Patients

Seq	Age	Sex	Outcome	Treatment
1	25.000 YR		Hospitalization| O

Terms

Patient problem · 3

• Cramp(s)
• Hair Loss
• Hemorrhage/Blood Loss/Bleeding

Product problems · 1

• Adverse Event Without Identified Device or Use Problem