BIB STENT PLACEMENT CATHETER 420 BB015

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for BIB STENT PLACEMENT CATHETER 420 BB015 manufactured by Numed, Inc..

MAUDE Entry Details

Report Number1318694-2019-00010
MDR Report Key8541022
Date Received2019-04-23
Date of Report2019-04-23
Date of Event2019-04-03
Date Mfgr Received2019-04-22
Device Manufacturer Date2018-07-26
Date Added to Maude2019-04-23
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 NameBIB STENT PLACEMENT CATHETER
Generic NameSTENT PLACEMENT CATHETER
Product CodeNVM
Date Received2019-04-23
Model Number420
Catalog NumberBB015
Lot NumberBIB-10303
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNUMED, INC.
Manufacturer Address2880 MAIN STREET HOPKINTON NY 12965 US 12965


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-23

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