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

MAUDE Adverse Event Report: CARBON MEDICAL TECHNOLOGIES, INC. MAMMOSTAR MARKER, RADIOGRAPHIC, IMPLANTABLE

  • 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
 

CARBON MEDICAL TECHNOLOGIES, INC. MAMMOSTAR MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number STAR1401
Device Problem Activation Problem (4042)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/09/2019
Event Type  malfunction  
Event Description
While using device the clip failed to deploy. No harm to the patient. This is a recurring problem. The manufacturer is aware and product has been returned to the manufacturer. Multiple lots are involved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAMMOSTAR
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
CARBON MEDICAL TECHNOLOGIES, INC.
1290 hammond rd ste 2
saint paul MN 55110
MDR Report Key9134075
MDR Text Key160519295
Report Number9134075
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSTAR1401
Device Catalogue NumberSTAR1401
Device Lot Number1902042A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/18/2019
Event Location Hospital
Date Report to Manufacturer09/30/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-