MAUDE Adverse Event Report: HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L BIOZORB; MARKER, RADIOGRAPHIC, IMPLANTABLE

Health Effect - Clinical Codes	Hematoma (1884); Failure of Implant (1924); Seroma (2069)
Date of Event	12/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Though i did not receive the march 13, 2024, letter that was reportedly sent from hologic to affected patients regarding biozorb and its recall, i learned about it online.I am writing to let you know that i had a biozorb device inserted in my right breast during a lumpectomy on (b)(6) 2022 that caused medical complications.Post-surgery, my breast turned black (i have fair skin) from a hematoma.After a (b)(6) visit to the emergency room when my breast was leaking blood and fluid, i was diagnosed with a seroma.In (b)(6), my surgeon, dr.(b)(6) determined that i was experiencing a foreign body reaction to the biozorb device, and it was surgically removed on (b)(6) 2024.The complications delayed my radiation, caused significant stress, and created additional risk and expense, not only because i needed an additional surgery, but also because the plan to complete my radiation in 2022 was not realized.I therefore had to meet my insurance deductible again in 2023 and pay more out of pocket for radiation.

• Brand Name: BIOZORB
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L
• MDR Report Key: 20212472
• Report Number: MW5159579
• Device Sequence Number: 7227317
• Product Code: NEU
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALLEGRA; ANASTRAZOLE; CALCIUM; LEVOTHYROXINE; LISINOPRIL; SERTRALINE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White