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

Model Number TUMARK-BREV-S-Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 01/03/2020

Event Type  Injury  

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 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
• Type of Device: TUMARK PROFESSIONAL Q FOR BREVERA STANDARD
• Manufacturer (Section D): SOMATEX MEDICAL TECHNOLOGIES GMBH; christopher.hansche@hologic.co; berlin, berlin 14199 ; GM 14199
• Manufacturer (Section G): SOMATEX MEDICAL TECHNOLOGIES GMBH; hohenzollerndamm 150/151; berlin, 14199 ; GM 14199
• Manufacturer Contact: christopher hansche ; hohenzollerndamm 150/151; berlin, 14199 ; GM 14199
• MDR Report Key: 12704897
• MDR Text Key: 278585392
• Report Number: 1000408433-2021-00002
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 04250195611321
• UDI-Public: 04250195611321
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K182082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 55