• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SOMATEX MEDICAL TECHNOLOGIES GMBH TUMARK PROFESSIONAL Q FOR BREVERA STANDARD Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTUMARK PROFESSIONAL Q FOR BREVERA STANDARD
Type of DeviceTUMARK 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 Key12704897
MDR Text Key278585392
Report Number1000408433-2021-00002
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K182082
Number of Events Reported1
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
Date FDA Received10/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/18/2020
Device Model NumberTUMARK-BREV-S-Q
Device Catalogue NumberTumark-BREV-S-Q
Device Lot Number117932
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/27/2021 Patient Sequence Number: 1
-
-