MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Asthma (1726); Dry Eye(s) (1814); Emotional Changes (1831); Erythema (1840); Extreme Exhaustion (1843); Fever (1858); Flatus (1865); Hair Loss (1877); Headache (1880); Itching Sensation (1943); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Rash (2033); Swelling (2091); Tinnitus (2103); Visual Disturbances (2140); Hot Flashes/Flushes (2153); Cramp(s) (2193); Dizziness (2194); Urinary Frequency (2275); Anxiety (2328); Depression (2361); Sensitivity of Teeth (2427); Sweating (2444); Cognitive Changes (2551); Weight Changes (2607); Constipation (3274)

Event Date 07/01/2010

Event Type  Injury  

Event Description

(b)(4).Im guessing at the date.I have had the following list: sharp stabbing pelvic pain, abnormal menses, hot flashes, night sweats, urgent/frequent urination, loss of bladder control, itching, celiac disease, hip pain, all over body aches, nausea, horrific gas, constipation, dental problems, heartburn, bowel issues, chronic metallic taste in mouth, chronic ringing in the ears , ongoing and debilitation dizziness/vertigo, brain fog, anxiety/panic attacks, mood swings, depression, vitamin d deficiency, hair loss, vision problems, severe bloating, migraines, tightness in the chest, asthma, reddening of facial skin, muscle twitches/cramping, loss of libido, weight gain, sensation of ovaries bouncing, sensation of severe pain in ovary area, bad body smells, exhaustion, dry eyes and skin, unexplained fever, swelling in the legs, rashes, plantar fasciitis, clenching of the jaw during sleep and more.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 6890801
• MDR Text Key: 87236981
• Report Number: MW5072410
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 49.000 YR