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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FOCAL THERAPEUTICS, A HOLOGIC COMPANY BIOZORB 3D BIOABSORBABLE MARKER; MARKER RADIOGRAPHIC, IMPLANTABLE
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FOCAL THERAPEUTICS, A HOLOGIC COMPANY BIOZORB 3D BIOABSORBABLE MARKER; MARKER RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number F020-LOG590537
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)
Event Date 01/14/2020
Event Type  Injury  
Event Description
A (b)(6) y/o female had significant chronic pain and swelling in her left breast after her lumpectomy and sentinel node biopsy for breast cancer in (b)(6) 2018.Patient felt that she had allergic reaction to the biosorb device that was placed at the time of surgery, and had skin testing with shaved parts of pla.The skin testing was clearly positive.She requested to have the biosorb remove.During surgery, the biosorb was identify intact without any signs of incorporation by the body.Fda safety report id # (b)(4).
 
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Brand Name
BIOZORB 3D BIOABSORBABLE MARKER
Type of Device
MARKER RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
FOCAL THERAPEUTICS, A HOLOGIC COMPANY
sunnyvale CA 94085
MDR Report Key9622123
MDR Text Key176300347
Report NumberMW5092435
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 Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberF020-LOG590537
Device Lot NumberA1-180606
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age44 YR
Patient Weight100
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