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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. BIOZORB MARKER MARKER, RADIOGRAPHIC, IMPLANTABLE

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HOLOGIC, INC. BIOZORB MARKER MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Breast Discomfort/Pain (4504)
Event Date 07/27/2018
Event Type  Injury  
Event Description
Patient reports pain approximately 2 years 10 months after surgery with biozorb marker implantation ((b)(4) 2018) for breast cancer. Ultimately, the biozorb was removed on (b)(6) 2018 followed by breast implantation. There are no further details about the surgical procedure, patient information, or surgeon information.
 
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Brand NameBIOZORB MARKER
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
Manufacturer Contact
uyen do
250 campus drive
marlborough, MA 01752
MDR Report Key11895001
MDR Text Key253027307
Report Number3009718212-2021-00001
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
PMA/PMN Number
K143484
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2021
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: 05/27/2021 Patient Sequence Number: 1
Treatment
CRESTOR, ZETIA, METFORMIN
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