MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Cyst(s) (1800); Pain (1994); Fibrosis (3167); No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Event Description

I was awoken in the middle of the night with a severe pain in my left pelvic area, radiating down my left leg.An er visit, transvaginal ultrasound and a follow-up with my gynecologist confirmed ovarian cysts, uterine fibroids, and an enlarged uterus.It is his opinion that the cysts and the fibroids were not large enough to be causing me the amount of pain i was experiencing.It was his opinion the essure coils may be protruding the tubes causing the severe pain.I was scheduled for a hysterectomy.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 7199889
• MDR Text Key: 97666751
• Report Number: MW5074615
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 32 YR
• Patient Weight: 77