NOVANT HLTH CARDIAC CATH TRAY (RCMWB)165 SAN23RCMWC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-16 for NOVANT HLTH CARDIAC CATH TRAY (RCMWB)165 SAN23RCMWC manufactured by Mex03 Mexico-juarez Presource.

MAUDE Entry Details

Report Number1423537-2020-00436
MDR Report Key9837805
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2020-02-19
Date Mfgr Received2020-02-19
Device Manufacturer Date2019-10-17
Date Added to Maude2020-03-16
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 ContactPATRICIA TUCKER
Manufacturer Street3651 BIRCHWOOD DR.
Manufacturer CityWAUKEGAN IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8478874152
Manufacturer G1MEX03 MEXICO-JUAREZ PRESOURCE
Manufacturer StreetC. ARCADIA 1580 , COL. TERRAZA
Manufacturer CityCD.JUAREZ , CHIHUAHUA CP 32599
Manufacturer CountryMX
Manufacturer Postal CodeCP 32599
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNOVANT HLTH CARDIAC CATH TRAY (RCMWB)165
Generic NameGENERAL SURGERY TRAY (KIT)
Product CodeLRO
Date Received2020-03-16
Model NumberSAN23RCMWC
Catalog NumberSAN23RCMWC
Lot Number331421
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEX03 MEXICO-JUAREZ PRESOURCE
Manufacturer AddressC. ARCADIA 1580 , COL. TERRAZA CD.JUAREZ , CHIHUAHUA CP 32599 MX CP 32599


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-16

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