MAMMOSTAR STAR1402

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-30 for MAMMOSTAR STAR1402 manufactured by Carbon Medical Technologies, Inc..

MAUDE Entry Details

Report Number9134560
MDR Report Key9134560
Date Received2019-09-30
Date of Report2019-09-04
Date of Event2019-08-28
Report Date2019-09-04
Date Reported to FDA2019-09-04
Date Reported to Mfgr2019-09-30
Date Added to Maude2019-09-30
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAMMOSTAR
Generic NameMARKER, RADIOGRAPHIC, IMPLANTABLE
Product CodeNEU
Date Received2019-09-30
Model NumberSTAR1402
Catalog NumberSTAR1402
Lot Number1902042A
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARBON MEDICAL TECHNOLOGIES, INC.
Manufacturer Address1290 HAMMOND RD STE 2 SAINT PAUL MN 55110 US 55110


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.