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U.S. Department of Health and Human Services

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

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FOCAL THERAPEUTICS BIOZORB MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number F0304
Device Problems Fracture (1260); Material Protrusion/Extrusion (2979)
Patient Problems Wound Dehiscence (1154); Necrosis (1971)
Event Date 09/02/2016
Event Type  malfunction  
Event Description
Surgery in early (b)(6): (r) needle localization segmental mastectomy with placement of a biozorb tissue marker. This was seen in surgical clinic by partner and registered nurse practitioner (rnp) for hematoma. Follow-up and monitoring occurred in surgical clinic six, nineteen, and twenty two days later. Dehiscence of breast wound with partial evacuation of hematoma prompting take-back to the operating room (or) twenty six days post-mastectomy. Delay of initiation of chemotherapy by 5 days for breast wound fistula overlying the biozorb. Notation of protrusion of a fractured prong of the biozorb device through the breast wound between cycle 3 and 4 of 4 cycles of chemotherapy. Last chemo treatment occurred in early (b)(6). The removal of the defective biozorb device and resection of the wound and fistula and resection of the fat necrosis in the segmentectomy bed, occurred at the end of (b)(6). (27 days delay to allow for improvement in the immunosuppression and poor wound healing associated with chemotherapy. ).
 
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Brand NameBIOZORB
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
FOCAL THERAPEUTICS
1010 stewart dr.
sunnyvale CA 94085
MDR Report Key6386915
MDR Text Key69366858
Report Number6386915
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberF0304
Device Lot NumberDI-160203
Other Device ID Number1861168
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/10/2017
Event Location Hospital
Date Report to Manufacturer02/10/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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