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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. V-MARK BREAST BIOPSY SITE MARKER

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ARGON MEDICAL DEVICES INC. V-MARK BREAST BIOPSY SITE MARKER Back to Search Results
Catalog Number 766914100SST
Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 05/14/2018
Event Type  malfunction  
Manufacturer Narrative
A review of the device history record was performed and no similar concerns were found. The investigation is currently on-going. Once the investigation is complete, a follow-up report will be submitted.
 
Event Description
After the procedure, the radiology noticed that the titanium marker (inside the needle) had come out with the needle and stuck to the skin of the patient. She had to sever the marker from the skin.
 
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Brand NameV-MARK BREAST BIOPSY SITE MARKER
Type of DeviceBREAST BIOPSY SITE MARKER
Manufacturer (Section D)
ARGON MEDICAL DEVICES INC.
1445 flat creek road
athens TX 75701
Manufacturer (Section G)
ARGON MEDICAL DEVICES INC.
Manufacturer Contact
gail smith
1445 flat creek road
athens, TX 75701
2144368995
MDR Report Key7601540
MDR Text Key111895343
Report Number1625425-2018-00064
Device Sequence Number1
Product Code NEU
Combination Product (y/n)Y
Reporter Country CodeFI
PMA/PMN Number
K053518
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Radiologic Technologist
Type of Report Initial,Followup
Report Date 01/01/2005,08/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue Number766914100SST
Device Lot Number11209176
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received01/14/2005
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/07/2018
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: 06/14/2018 Patient Sequence Number: 1
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