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

Model Number	F0303
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Hematoma (1884); Seroma (2069); Fluid Discharge (2686)
Date of Event	09/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.The device involved in this event was returned for evaluation purposes.Lab inspection of the returned device confirmed an intact device, with deformation along the device length (flattened).As the photograph provided by the complainant confirms an intact device with no deformation in-situ, the deformation can be attributed to shipping & handling of the device prior to arrival in a flat container, and lack of sufficient return packaging.A product-specific discrepancy that could have caused or contributed to the event was not observed during the lab analysis.Biocompatibility and sterility testing have been performed per the design history file for the biozorb device.All results acceptable.The exact cause of the patient event cannot be determined to a certainty based on the patient history, but it is unlikely device related and likely a complication of radiation therapy.
Event or Problem Description
It was reported that the patient had a lumpectomy and biozorb placement on (b)(6)2016.The patient developed a large hematoma postop with manual lymphatic drainage of the breast.Chemotherapy was completed on (b)(6), 2016.The patient presented on (b)(6) 2016 with acute breast redness and a wound, cultures were negative and a wound vac was started.The wound worsened and the biozorb could be seen in the wound and was removed during wound treatment on (b)(6) 2016.No further complications were reported, and the wound was healing well.

• Brand Name: BIOZORB
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer Contact: daniel guevara ; coyol free zone building b24; alajuela; alajuela, 20102- CRI ; CS 20102 CRI
• MDR Report Key: 21159832
• Report Number: 1222780-2025-01011
• Device Sequence Number: 7631583
• Product Code: NEU
• UDI-Device Identifier: 00851766006023
• UDI-Public: (01)00851766006023(17)170701(10)C1-150217
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K143484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 07/01/2017
• Device Model Number: F0303
• Device Catalogue Number: F0303
• Device Lot Number: C1-150217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2016
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 53 YR
• Patient Sex: Female