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U.S. Department of Health and Human Services

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

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CARBON MEDICAL TECHNOLOGIES, INC. MAMMOSTAR¿ MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number STAR1401
Device Problem Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2020
Event Type  malfunction  
Event Description
Device failed to deploy as intended.
 
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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 Key9864743
MDR Text Key184450436
Report Number9864743
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 02/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSTAR1401
Device Catalogue NumberSTAR1401
Device Lot Number1908171A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/19/2020
Event Location Hospital
Date Report to Manufacturer03/23/2020
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

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