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	Bacterial Infection (1735); Erythema (1840)
Date of Event	10/30/2019
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 not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
Event or Problem Description
It was reported that an 85-year-old patient received a biozorb marker (f0303) on (b)(6) 2019, during a lumpectomy due to a previous biopsy on (b)(6) 2019 that revealed triple negative idc.Patient received chemotherapy due to the triple negative status of her tumor, patient received one treatment of chemo and refused the remainder of the course, additionally patient received radiotherapy from (b)(6) 2019 up until (b)(6) 2019.It was reported that following her radiation treatment and one treatment of chemo, the patient developed an infection 11 month post-surgery.Patient presented to a physician clinic on (b)(6) 2020, with red area to the lumpectomy site and a small white pimple on the lateral side of the incision.The physician attempted aspiration and filled a 3-cc syringe with pus from the area.The physician applied mild pressure to the area and more pus came out.She aspirated a total of 8 cc of pus.The exudate was sent for culture and grew klebsiella.Patient was started on bactrim and sent for imaging.The physician reported that the biozorb appeared blurred on the diagnostic ultrasound but otherwise unremarkable.Patient was seen on (b)(6) 2020, and additional 3.5 cc of pus were aspirated.No additional information.Medical history: patient had previous history of uterine cancer 1 year before breast cancer.

• 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 ; 562 parkway; coyol free zone building b24; alajuela, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 20758670
• Report Number: 1222780-2024-00703
• Device Sequence Number: 13134949
• Product Code: NEU
• UDI-Device Identifier: 00851766006023
• UDI-Public: (01)00851766006023(17)210731(241)F0303(10)C1-190207
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: F0303
• Device Catalogue Number: F0303
• Device Lot Number: C1-190207
• 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: 09/16/2020
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2019
• 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: Other
• Patient Age: 85 YR
• Patient Sex: Female