COVERED MOUNTED CP STENT 428 CMCP014

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-07 for COVERED MOUNTED CP STENT 428 CMCP014 manufactured by Numed, Inc..

MAUDE Entry Details

Report Number1318694-2019-00020
MDR Report Key9162941
Date Received2019-10-07
Date of Report2019-10-07
Date of Event2019-08-23
Date Mfgr Received2019-09-10
Date Added to Maude2019-10-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. NICHELLE LAFLESH
Manufacturer Street2880 MAIN STREET
Manufacturer CityHOPKINTON NY 12965
Manufacturer CountryUS
Manufacturer Postal12965
Manufacturer Phone3153284491
Manufacturer G1NUMED, INC.
Manufacturer Street2880 MAIN STREET
Manufacturer CityHOPKINTON NY 12965
Manufacturer CountryUS
Manufacturer Postal Code12965
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCOVERED MOUNTED CP STENT
Generic NameAORTIC STENT SYSTEM
Product CodePNF
Date Received2019-10-07
Returned To Mfg2019-09-25
Model Number428
Catalog NumberCMCP014
Lot NumberCMCP-2004
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNUMED, INC.
Manufacturer Address2880 MAIN STREET HOPKINTON NY 12965 US 12965


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-07

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