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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 STAR1402
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/06/2019
Event Type  malfunction  
Event Description
The device failed to deploy. No harm to the patient.
 
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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 Key8939263
MDR Text Key155809079
Report Number8939263
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 08/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSTAR1402
Device Catalogue NumberSTAR1402
Device Lot Number1903078A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/22/2019
Event Location Hospital
Date Report to Manufacturer08/28/2019
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

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