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

Model Number STAR1402

Device Problems Defective Device (2588); Activation, Positioning or Separation Problem (2906)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2019

Event Type  malfunction  

Event Description

The device in this event was not used on the patient.The device was deployed prior to use and did not work as intended.

• Brand Name: MAMMOSTAR
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): CARBON MEDICAL TECHNOLOGIES, INC.; 1290 hammond rd ste 2; saint paul MN 55110
• MDR Report Key: 9134560
• MDR Text Key: 160540169
• Report Number: 9134560
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: STAR1402
• Device Catalogue Number: STAR1402
• Device Lot Number: 1902042A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA