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

Model Number	F0202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Loss of Range of Motion (2032); Rash (2033); Seroma (2069); Deformity/ Disfigurement (2360); Numbness (2415); Breast Mass (2439); Breast Discomfort/Pain (4504); Swelling/ Edema (4577)
Date of Event	09/23/2021
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 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 a patient received a biozorb implant on (b)(6) 2021.It is reported that the patient has experienced fatigue as well as pain, seroma, petechia, a hard lump, necrosis at the site of implantation, swelling, numbness in the shoulder, loss of range of motion and lymphedema.It is reported that the patient is scheduled to have the biozorb implant removed on (b)(6) 2026.No further information is currently available.
Additional Manufacturer Narrative
Hologic is in receipt of medwatch report (b)(4) supplemental mdr submitted due to additional information received via medwatch report (b)(4) it was reported that the patient also experienced "disfiguration as well as rash" in the area of the biozorb implant.Additionally, the following concomitant medications were reported: aspirin 81, benicar 40mg, coq10, krill oil, lumigan eye drops, metoprolol, plaquenil, repatha injection, vitamin d3 5000iu.

• 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: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 24729453
• Report Number: 1222780-2026-00141
• Device Sequence Number: 21136015
• Product Code: NEU
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2026

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: 02/28/2023
• Device Model Number: F0202
• Device Catalogue Number: F0202
• Device Lot Number: A1-200915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/15/2026; 09/24/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/16/2026; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2020
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 204 LB
• Patient Race: White