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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER ESSURE BIRTH CONTROL; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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BAYER ESSURE BIRTH CONTROL; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abdominal Pain (1685); Chest Pain (1776); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Swelling (2091); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Anxiety (2328); Depression (2361); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Heavier Menses (2666)
Event Date 04/20/2018
Event Type  Injury  
Event Description
I had essure implants 3 months ago after i was told from the dr that it's safe.Now i have been suffering with a lot of side effects among which is the brain fog and the memory loss, along with abdominal pain.Back pain, dizziness, nausea, spinal pain, tingling, and swollen foot and hand.Heat sensation all over my body, chest pain.I am not able to walk more than 5/10 minutes.Panic attack, depression, spotting, light periods with severe pain, fatigue, nickel allergy reaction, and a lot more.I was working out everyday now i can't go out because i am not able to stand or walk a lot.It's affecting my life and my family's life.Please consider doing something about it.It's in your hand.Thanks.
 
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Brand Name
ESSURE BIRTH CONTROL
Type of Device
TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
BAYER
MDR Report Key7453822
MDR Text Key106428739
Report NumberMW5076665
Device Sequence Number1
Product Code HHS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/20/2018
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 Received04/23/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age38 YR
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