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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 Activation Problem (4042)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/03/2019
Event Type  malfunction  
Event Description
A patient underwent ultrasound core biopsy, l breast. After biopsies were obtained, radiologist attempted to place clip in area but clip would not deploy. Procedure was completed without placement of breast clip. Manufacturer response for mammotome, mammotome mammostar biopsy site identifier (per site reporter). Equipment failure reported to debacore customer service. No product to return.
 
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Brand NameMAMMOSTAR¿
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
CARBON MEDICAL TECHNOLOGIES, INC.
1290 hammond road ste 2
saint paul MN 55110
MDR Report Key8415998
MDR Text Key138657300
Report Number8415998
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 Other Health Care Professional
Type of Report Initial
Report Date 03/01/2019,02/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSTAR1402
Device Catalogue NumberSTAR1402
Device Lot Number1809205A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/01/2019
Event Location Hospital
Date Report to Manufacturer03/13/2019
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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