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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FOCAL THERAPEUTICS BIOZORB MARKER, RADIOGRAPHIC, IMPLANTABLE

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FOCAL THERAPEUTICS BIOZORB MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Granuloma (1876); Inflammation (1932); Pain (1994); Discomfort (2330)
Event Date 06/01/2018
Event Type  Injury  
Event Description
On march 5th i had a lumpectomy performed on my right breast. The surgeon implanted a device called biozorb. It was very uncomfortable and painful. At around 12 weeks after surgery i was due to start radiation therapy but my breast started to turn red and then a lump protruded and the area turned purple. It felt like there were bugs crawling around under my skin. My doctor was out of town so i had to go the emergency room. I was prescribed some antibiotics, my radiologist when he saw it prescribed me a different antibiotic and then after sending photos to my surgeon she prescribed a third antibiotic. Then i developed retraction of the skin and deviation of the nipple. I had to have a needle aspiration to see if it was a hematoma but that was negative. Finally, the surgeon recommended removing the biozorb device. I opted to have a complete mastectomy as i didn¿t like the way my breast was now deformed and the radiation would maybe make it worse. As soon as the breast tissue and biozorb device was removed my skin returned to a normal color and pain free. The pathology of the breast tissue showed the presence of granulomatous inflammation, foreign body type, multiple multinucleated foreign body type giant cells. This device was pushed on me and made to sound very safe and that it would help with the cosmetic appearance of my breast after the lumpectomy. I wish i had just had the breast removed and done with. I have been under treatment for 14 months and even now i have to have one last reconstruction surgery next week.
 
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Brand NameBIOZORB
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
FOCAL THERAPEUTICS
MDR Report Key8306404
MDR Text Key135685615
Report NumberMW5083699
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 01/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2019
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
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: 02/04/2019 Patient Sequence Number: 1
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