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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 Device Or Device Fragments Location Unknown (2590); Patient-Device Incompatibility (2682)
Patient Problems Abdominal Pain (1685); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Anxiety (2328); Depression (2361); Abdominal Distention (2601); Weight Changes (2607); Pregnancy (3193)
Event Date 01/19/2007
Event Type  Injury  
Event Description
(b)(4).Had essure placed in (b)(6) 2006 after the birth of my 2nd child.In (b)(6) of 2007, i was admitted into the hospital due to severe abdominal pain for over 12 hours.Doctors could not find the source of the pain and released me after 24 hours.(b)(6) 2007 after missing my cycle, it was discovered that i was pregnant.After visiting with another physician and a conference call with conceptus and the physician and getting no positive answers for the safety of myself and/or my fetus, i decided i wanted to abort the pregnancy as my 2 children deserved their mother.After the dnc was complete, the doctor ordered several x-rays to be done and only 1 coil has been located.To this date, i still have no answers of where the other coil is.Later that year, i did have a tubal ligation to prevent any further pregnancies.Since that time i have gained over 30 lbs, large amounts of hair loss, constant diarrhea, constant fatigue, bloating, headaches, hip pain, pelvic pain, leg aches and throbs, extreme moodiness, depression, anxiety attacks, abnormal hair growth on neck and breasts.
 
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Brand Name
ESSURE
Manufacturer (Section D)
BAYER
MDR Report Key4976455
MDR Text Key21093705
Report NumberMW5045164
Device Sequence Number1
Product Code HHS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Source Type Invalid Data
Reporter Occupation Patient
Type of Report Initial
Report Date 07/08/2015
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 Other
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/06/2015
Patient Sequence Number1
Treatment
NEXIUM
Patient Outcome(s) Hospitalization; Life Threatening; Other;
Patient Age40.000 YR
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