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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FOCAL THERAPEUTICS (A HOLOGIC COMPANY) BIOZORB MARKER MARKER, RADIOGRAPHIC, IMPLANTABLE

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FOCAL THERAPEUTICS (A HOLOGIC COMPANY) BIOZORB MARKER MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number F0203
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Increased Sensitivity (4538)
Event Date 11/19/2020
Event Type  Injury  
Event Description
Nurse from (b)(6) hospital reports patient experiencing redness and tenderness with biozorb implantation approximately 3 weeks after surgery. Patient placed on antibiotics, but redness increased. Ultimately, the bizorb marker was removed.
 
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Brand NameBIOZORB MARKER
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
FOCAL THERAPEUTICS (A HOLOGIC COMPANY)
sunnyvale CA
Manufacturer Contact
kristin fornieri
36 & 37 apple ridge road
danbury, CT 06810
2037318491
MDR Report Key10984726
MDR Text Key220716139
Report Number3009718212-2020-00003
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
Type of Report Initial
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberF0203
Device Lot NumberJ2-190610
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2020
Was Device Evaluated by Manufacturer? No
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: 12/10/2020 Patient Sequence Number: 1
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