MAUDE Adverse Event Report: SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK PROFESSIONAL Q FOR BREVERA STANDARD

Model Number	TUMARK-BREV-S-Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event has been reported initially by a patient to the german competent authority.The competent authority forwarded the information about the event to somatex.
Event or Problem Description
Pain after vacuum biopsy with clip marking.The q-shaped clip from somatex stings and presses in the right breast tissue just under the skin.Pain comes again and again since beginning of year 2020.Clip has been removed at (b)(6) 2021.After the pain started in (b)(6) 2020 the patient visited several physicians for examination.Despite this, the pain persisted.After the clip was removed the pain went away.

• Brand Name: TUMARK PROFESSIONAL Q FOR BREVERA STANDARD
• Common Device Name: TUMARK PROFESSIONAL Q FOR BREVERA STANDARD
• Manufacturer (Section D): SOMATEX MEDICAL TECHNOLOGIES GMBH; christopher.hansche@hologic.co; berlin, berlin 14199 ; GM 14199
• MDR Report Key: 12704897
• Report Number: 1000408433-2021-00002
• Device Sequence Number: 19840454
• Product Code: NEU
• UDI-Device Identifier: 04250195611321
• UDI-Public: 04250195611321
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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: 09/18/2020
• Device Model Number: TUMARK-BREV-S-Q
• Device Catalogue Number: Tumark-BREV-S-Q
• Device Lot Number: 117932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 55