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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC ADIANA

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HOLOGIC ADIANA Back to Search Results
Event Date 05/18/2012
Event Type  Injury  
Event Description

Since i have had the adiana implants inserted, i've been progressively symptomatic. Beginning from the time i had the procedure, i've had severely heavy bleeding with periods, irregular periods, severe cramping, near constant pain in right lower abdomen (ovary?), stomach bloating to point of looking (b)(6) pregnant, severe lower back pain where i almost can't even walk at times, hair loss, teeth are decaying rather rapidly when i used to have healthy teeth, loss of appetite, impossible to lose any weight, dizzy spells, migraine headaches, irritability, ringing ears, allergies worsened, severe fatigue, skin breaking out, breast tenderness, brain fog/short term memory loss. I am sure that i've missed several symptoms. I did not feel this horrible ever until after i got the adiana implants. I will be looking for a doctor educated with these to see, and will probably need a hysterectomy to remove them. Had 2 gyn appointments and mentioned the heavy periods to them, one ordered an ultrasound to look for possible issues, said ultrasound was "clear".

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Brand NameADIANA
Type of DeviceADIANA
Manufacturer (Section D)
MDR Report Key5117708
Report NumberMW5056710
Device Sequence Number1
Product CodeHHS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Date Received: 09/27/2015 Patient Sequence Number: 1