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

Model Number	STAR1401
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Device failed to deploy as intended.

• Brand Name: MAMMOSTAR¿
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): CARBON MEDICAL TECHNOLOGIES, INC.; 1290 hammond rd ste 2; saint paul MN 55110
• MDR Report Key: 9864743
• Report Number: 9864743
• Device Sequence Number: 3041558
• Product Code: NEU
• UDI-Device Identifier: 00858015005424
• UDI-Public: (01)00858015005424(17)240913(10)1908171A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/19/2020
• Report Date (Section F): 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: STAR1401
• Device Catalogue Number: STAR1401
• Device Lot Number: 1908171A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/19/2020