MAUDE Adverse Event Report: SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK VISION FOR EVIVA STANDARD; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	TUMARK-E13-S-VISION
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the device at the time of this report.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.
Event or Problem Description
Hologic has received correspondence arising from litigation.The litigation alleges that a patient received a tumark vision for eviva standard breast marker on (b)(6) 2021.It is further alleged that the patient developed a "severe inflammatory reaction," and the device was surgically removed on (b)(6) 2025.Additionally, it is reported that diagnosis of the excised tissue confirmed the presence of "foreign body granuloma.".

• Brand Name: TUMARK VISION FOR EVIVA STANDARD
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): SOMATEX MEDICAL TECHNOLOGIES GMBH; kaiserin-augusta-allee 112/113; berlin, 10553 ; GM 10553
• Manufacturer (Section G): SOMATEX MEDICAL TECHNOLOGIES GMBH; kaiserin-augusta-allee 112/113; berlin, 10553 ; GM 10553
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 25057175
• Report Number: 3030927217-2026-00002
• Device Sequence Number: 9299981
• Product Code: NEU
• UDI-Device Identifier: 04250195611222
• UDI-Public: (01)04250195611222(11)190524(17)240523(10)190509009
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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: 05/23/2024
• Device Model Number: TUMARK-E13-S-VISION
• Device Catalogue Number: TUMARK-E13-S-VISION
• Device Lot Number: 190509009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2019
• 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 Sex: Unknown