• 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, INC BIOZORB MARKER TISSUE MARKER

  • 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, INC BIOZORB MARKER TISSUE MARKER Back to Search Results
Model Number F0203
Device Problems Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 08/11/2016
Event Type  Injury  
Manufacturer Narrative
Device returned (b)(6) 2016 for investigation and the evaluation is not yet complete. A supplemental report will be submitted when the manufacturer's investigation is complete.
 
Event Description
Surgeon reported that patient presented with portion of device visible within her original lumpectomy incision approximately 10 months after surgery and radiation treatment for breast cancer. Patient was taken to surgery the following day to remove the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIOZORB MARKER
Type of DeviceTISSUE MARKER
Manufacturer (Section D)
FOCAL THERAPEUTICS, INC
1010 stewart dr.
sunnyvale CA 94085
Manufacturer (Section G)
FOCAL THERAPEUTICS, INC
1010 stewart dr.
sunnyvale CA 94085
Manufacturer Contact
hanna michelsen
1010 stewart dr.
sunnyvale, CA 94085
4089627010
MDR Report Key6001607
MDR Text Key56539073
Report Number3009718212-2016-00001
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143484
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date11/01/2017
Device Model NumberF0203
Device Lot NumberB2-150601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/05/2016 Patient Sequence Number: 1
-
-