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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC BIOZORB MARKER MARKER, RADIOGRAPHIC, IMPLANTABLE
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HOLOGIC BIOZORB MARKER MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Device Problem Chemical Problem (2893)
Patient Problems Pain (1994); Anxiety (2328)
Event Date 01/28/2019
Event Type  Injury  
Event Description
My doctor placed a "biozorb marker" in my left breast after breast cancer surgery, without my knowledge or approval. It was supposed to help with radiation but my rad doc said it was not necessary at all. It is a constant source of pain and anxiety. It sends pain through my back and all the way through my breast if i hit it or bump it. It was supposed to dissolve over 12 months but i am a year and 3 months out and it has not changed. I want it out but my doctor tells me it will cause more problems if i have it removed. I absolutely hate this thing and wished i had been asked before placing this garbage in my body. Shame on the makers of this product for giving cancer patients one more problem to deal with; focal rx inc. Fda safety report id# (b)(4).
 
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Brand NameBIOZORB MARKER
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
HOLOGIC
MDR Report Key9915593
MDR Text Key186308443
Report NumberMW5094013
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 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
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: 04/01/2020 Patient Sequence Number: 1
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