MAUDE Adverse Event Report: SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK® PROFESSIONAL X FOR BREVERA® STANDARD; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	TUMARK-BREV-S-V-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.H3: 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 after a tumark implantation procedure on (b)(6) 2024 the patient experienced a rash after the procedure.No other information available.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.H3: 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 after a tumark implantation procedure on (b)(6) 2024, the patient experienced a rash after the procedure.No other information available.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.H3: 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.Correction submission date is 01/09/2025.
Event or Problem Description
It was reported that after a tumark implantation procedure on (b)(6) 2024, the patient experienced a rash after the procedure.No other information available.

• Brand Name: TUMARK® PROFESSIONAL X FOR BREVERA® STANDARD
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): SOMATEX MEDICAL TECHNOLOGIES GMBH; hohenzollerndamm 150/151; berlin, 14199 ; GM 14199
• Manufacturer (Section G): SOMATEX MEDICAL TECHNOLOGIES GMBH; hohenzollerndamm 150/151; berlin, 14199 ; GM 14199
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 21120015
• Report Number: 1000408433-2025-00001
• Device Sequence Number: 18001259
• Product Code: NEU
• UDI-Device Identifier: 04250195612106
• UDI-Public: (01)04250195612106(11)230901(17)280831(10)52815
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2025

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
• Operator of Device: Health Professional
• Device Model Number: TUMARK-BREV-S-V-02
• Device Catalogue Number: TUMARK-BREV-S-V-02
• Device Lot Number: 52815
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 12/10/2024
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/09/2025; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2023
• 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 Sex: Female