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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 Problem Patient-Device Incompatibility (2682)
Patient Problems Death (1802); Miscarriage (1962); Pain (1994); Pregnancy (3193)
Event Date 05/31/2012
Event Type  Death  
Event Description
(b)(4).I was implanted with the essure device in my gynecologists office.Not only did i have immense pain, i've had nothing but adverse effects since then, but my doctor refused to see me, and my medical records from my implanting doctor as well as other doctors i went to seeking help are falsified.Yes, i do have proof and documentation of my allegations.My unborn child that i conceived after a confirmation hsg test that claimed i was 100% occluded, was miscarried early in my pregnancy, which is why i used the check mark on the box that says death.My unborn child died as a result of this device.
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Brand Name
Manufacturer (Section D)
MDR Report Key4899748
MDR Text Key6830220
Report NumberMW5043734
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 05/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Is the Reporter a Health Professional? No
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age40.000 YR