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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 Pain (1994); Tingling (2171); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165)
Event Date 10/01/2012
Event Type  Injury  
Event Description
(b)(4).I started having pain in my hips to the point that it hurts to sit or even stand.My period super heavy to the point my husband took me to hospital and i was told there that i almost had to have a blood transfusion and till this day, i have blood clots and heavy bleeding.I get sharp shooting pains in my back, tingling in my arms and legs and hands and feet.The top part of my arms hurt so bad, they like they are bruised and hurts to straighten or bend them.My neck and shoulders hurt.When i first had the coils put in, i was told to come back to make sure the coils were in place by them having a dye put in me but when they did the xray they only seen one, i asked where the other one went and they said it probably fell out but now i am not sure, i went back to dr and they put another coil in to replace the one they didn't see in xray and i never went to have them checked from that point.I have had nothing but issues with my body since i have had essure done.
 
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Brand Name
ESSURE
Manufacturer (Section D)
BAYER
MDR Report Key4196705
MDR Text Key16857608
Report NumberMW5038741
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 10/14/2014
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 Received10/23/2014
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age37.000 YR
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