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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FOCAL THERAPUTICS BIOZORB MARKER MARKER, RADIOGRAPHIC, IMPANTABLE

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FOCAL THERAPUTICS BIOZORB MARKER MARKER, RADIOGRAPHIC, IMPANTABLE Back to Search Results
Model Number F0304
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Tissue Breakdown (2681)
Event Date 07/25/2019
Event Type  Injury  
Event Description
Delayed wound complication of the breast, consisting of skin breakdown at the surgical/radiation site overlying a biozorb marker. Surgical management was required for wound debridement and removal of the remaining elements of the bioabsorbable marker.
 
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Brand NameBIOZORB MARKER
Type of DeviceMARKER, RADIOGRAPHIC, IMPANTABLE
Manufacturer (Section D)
FOCAL THERAPUTICS
sunnyvale CA
Manufacturer Contact
george marcel
1010 stewart drive
sunnyvale, CA 94085
4089627003
MDR Report Key8918564
MDR Text Key157761960
Report Number3009718212-2019-00001
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberF0304
Device Lot NumberPENDING
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/21/2019 Patient Sequence Number: 1
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