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

MAUDE Adverse Event Report: HOLOGIC, INC. TRIMARK BIOPSY SITE TISSUE MARKER DEVICE

  • 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
 

HOLOGIC, INC. TRIMARK BIOPSY SITE TISSUE MARKER DEVICE Back to Search Results
Model Number TRIMARK-EVIVA-13
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/10/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. Device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications.
 
Event Description
It was reported that after deploying the biopsy site identifier, post biopsy mammography images were obtained. The radiologist noted what appears to be a metallic foreign body in the images that does not correlate to the site marker and was not seen on post biopsy imaging. The reported device has been requested to return to hologic for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRIMARK
Type of DeviceBIOPSY SITE TISSUE MARKER DEVICE
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
Manufacturer Contact
kristin fornieri
36 & 37 apple ridge road
danbury, CT 06810
2037318491
MDR Report Key11628666
MDR Text Key247208868
Report Number1222780-2021-00071
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023450
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTRIMARK-EVIVA-13
Device Catalogue NumberTRIMARK-EVIVA-13
Device Lot Number20M08RJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-