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U.S. Department of Health and Human Services


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Model Number SMARK-EVIVA-13
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Fatigue (1849); Glaucoma (1875); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Skin Irritation (2076); Swelling (2091); Visual Impairment (2138); Sweating (2444); Shaking/Tremors (2515)
Event Date 02/16/2018
Event Type  Injury  
Event Description
On (b)(6) 2018 i had a breast biopsy and a hologic securemark marker was implanted. Four days later, i began feeling shaky and developed an unbearable stiff neck with large swollen lymph node. Days later i had intense involuntary shaking, night sweats, extreme fatigue and joint aches. During this time i had a few episodes where every tooth in my mouth along with my jaw ached intensely. The skin on my face also showed large areas of broken blood vessels at the surface. I then developed heel pain and could not put any pressure on my heels for the first few hrs of each day as i felt that they would explode. This lasted for 1 week. Following that i noticed that my vision was a bit off. I began to feel as though i was looking through a milky haze. I called my optometrist on a saturday and had me come in immediately. He said that i had developed uveitis (inflammation) in both eyes. He put me on steroid drops and also began dilating my eyes. I went back for a re-check two days later and he sent met to ophthalmologist in the practice because there was no change in the inflammation and the pressure in my eyes was very high. The ophthalmologist then referred me to a specialist at (b)(6) institute. This dr said that i had developed multifocal choroiditis with pan uveitis and retinal vasculitis. I have many large lesions in the choroid layer of my eyes, along with thousands of very small lesions. The vasculature in my eyes is also leaky. I had to be dilated for 20 days around the clock and my eyesight has been compromised (i see distortions where the large lesions are and can see the thousands of small lesions as translucent gray dots under certain lighting conditions). He and others tested me for a whole range of autoimmune disorders and infections. All tests were negative. Blood tests did reveal significant increases in inflammatory markers such as sedimentation rate and c-reactive protein. I began wondering if the breast marker implanted during the biopsy was to blame for this systemic inflammatory response. Given that my vision had been compromised my primary care physician and i decided the best course of action was to have the marker removed. I had breast surgery to remove the marker roughly one month following the onset of these symptoms. The surgeon said that she would remove tissue surrounding the marker and send it off to pathology. The pathology report noted reactive surgical site changes in the tissue surrounding the marker. Within a few days of the marker removal i felt much better, the fatigue and aches/pains had subsided completely. My dr ordered another blood draw to recheck the sedimentation rate and c-reactive problem levels, both were in the normal range. I saw the eye specialist 5 days after the surgery, he repeated the angiogram and saw no change in the lesions or retinal vasculitis. I've continued on steroid and pressure eye drops, and have developed steroid induced glaucoma. I will remain on pressure reducing eye drops for a total of 3 months. My vision has not improved at this point not i have developed ocular rosacea and rosacea following this inflammation event. I requested the lot number for the marker from the clinic that implanted it so that i could contact the mfr to see if they possibly had a recall on the marker that was used. Unfortunately the clinic does not track lot numbers, which i believe is extremely poor medical practice. Without the lot number it would be impossible to know this device was expired or from a lot that was defective. I do plan to contact the mfr directly so that they are aware of the circumstances that arose following my biopsy.
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Manufacturer (Section D)
MDR Report Key7464320
MDR Text Key107021075
Report NumberMW5076769
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSMARK-EVIVA-13
Device Catalogue NumberSMARK-EVIVA-13
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/25/2018 Patient Sequence Number: 1