• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FOCAL THERAPEUTICS BIOZORB MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994)
Event Date 11/16/2016
Event Type  Injury  
Event Description
I had a partial mastectomy where a biozorb device was implanted in my breast. It was supposed to be reabsorbed in a year, it has now been close to three years, and it is still not fully absorbed and not only has caused me chronic pain issues since its replacement but also inflammation of my breast if there is even the slightest impact from exercise or even someone just bumping into me. Had i been fully informed of the honest and negative effects of this device i would never have agreed to have this device implanted. It has prevented me from being able to get post cancer mammograms because of the pain issue. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIOZORB
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
FOCAL THERAPEUTICS
MDR Report Key8915911
MDR Text Key155249351
Report NumberMW5089224
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2019
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: 08/20/2019 Patient Sequence Number: 1
-
-