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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 Problems Patient-Device Incompatibility (2682); Output Problem (3005)
Patient Problem Implant Pain (4561)
Event Date 04/29/2020
Event Type  Injury  
Event Description
Left breast lumpectomy and biozorb implant placement performed. Biozorb implant source of constant pain, requiring additional medical follow-up, pain medication and physical therapy. I also had reconstructive surgery performed on the same day by a plastic surgeon. Have large disfiguring 'divet' where the tumor was and the biozorb was placed. Both of my surgeons told me the biozorb was supposed to improve the cosmetic outcome which it failed to do. I am 6 months s/p surgery and the pain has not lessened, nor the size of the biozorb implant. I was told it would absorb in 12 months and now the breast surgeon is saying 2 years. I will probably need to have the biozorb removed leading to additional surgery and now facing mastectomy versus lumpectomy. At the very least, i am facing additional reconstructive surgery. Biozorb is such a bad product. How did it ever get approval?; fda safety report id# (b)(4).
 
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Brand NameBIOZORB
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
FOCAL THERAPEUTICS
MDR Report Key10860407
MDR Text Key217145401
Report NumberMW5097946
Device Sequence Number1
Product Code NEU
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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: 11/17/2020 Patient Sequence Number: 1
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