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U.S. Department of Health and Human Services

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

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FOCAL THERAPEUTICS BIOZORB MARKER FOR BREAST MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Irritation (1941); Tissue Damage (2104); Discharge (2225)
Event Date 04/09/2019
Event Type  Injury  
Event Description
Breast conservation surgery with biozorb implanted on (b)(6) 2019 at (b)(6) medical center ((b)(6) hosp) by dr (b)(6). The device has now caused an open wound, with drainage. This is within an irradiated field. I will now need add'l surgery to remove this. I may need hyperbaric oxygen. I have diabetes so am high risk. Saw my surgeon who is now recommending add'l surgery. Open wound after radiation. Fda safety report id # (b)(4).
 
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Brand NameBIOZORB MARKER FOR BREAST
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
FOCAL THERAPEUTICS
MDR Report Key8843188
MDR Text Key152974587
Report NumberMW5088532
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 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
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: 07/29/2019 Patient Sequence Number: 1
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