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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER ESSURE
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BAYER ESSURE Back to Search Results
Device Problems Difficult or Delayed Positioning (1157); Patient-Device Incompatibility (2682)
Patient Problems Emotional Changes (1831); Flatus (1865); Hair Loss (1877); Headache (1880); Itching Sensation (1943); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Dizziness (2194); Depression (2361); Confusion/ Disorientation (2553); Abdominal Distention (2601); Heavier Menses (2666)
Event Date 10/29/2012
Event Type  Injury  
Event Description
(b)(4).When i had essure implanted on (b)(6) 2012, they had trouble putting in th right coil.I was so painful that i cried.I had heavy bleeding from that time for several weeks and my periods were not normal for about a year having 2 in one month.I have had medical problems since implantation that i did not have before.I have had irregular periods, painful periods, huge clots with my period, stiffness when standing and pain in lower back, especially after having sex, painful sex, cramping and terrible bloating at all times looking like i am pregnant, skin breakouts with clear fluid that leaves bad scars on face, skin itching, loss of libido and sexual dysfunction, pelvic pain, abdominal pain, migraines, nausea and fullness when i eat, spasms, fluttering feeling in abdomen area, metabolic taste in mouth, dizziness, excessive gas, extreme brain fog, forgetting stuff, confusion, mood swings, depression, feeling sad all the time, hair loss, heartburn, vitamin d deficiency.
 
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Brand Name
ESSURE
Manufacturer (Section D)
BAYER
MDR Report Key6887649
MDR Text Key87175325
Report NumberMW5072327
Device Sequence Number1
Product Code HHS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/10/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Is the Reporter a Health Professional? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age36.000 YR
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