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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FOCAL THERAPEUTICS, INC BIOZORB MARKER TISSUE MARKER

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FOCAL THERAPEUTICS, INC BIOZORB MARKER TISSUE MARKER Back to Search Results
Model Number F0304
Device Problems Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); No Code Available (3191)
Event Date 12/19/2016
Event Type  Injury  
Event Description
Surgeon reports that patient presented with portion of device visible through her original lumpectomy incision.
 
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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 Key6252057
MDR Text Key64900640
Report Number3009718212-2017-00002
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,Followup
Report Date 04/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2018
Device Model NumberF0304
Device Lot NumberD1-160203
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/13/2017 Patient Sequence Number: 1
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