SUPERNO2VA SATELLITE KIT MEDIUM SSM-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-11 for SUPERNO2VA SATELLITE KIT MEDIUM SSM-20 manufactured by Vyaire Medical.

MAUDE Entry Details

Report Number8030673-2020-00090
MDR Report Key9816982
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-11
Date of Report2020-02-13
Date of Event2020-02-12
Date Mfgr Received2020-02-13
Date Added to Maude2020-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. MINDY FABER
Manufacturer Street26125 N. RIVERWOODS BLVD.
Manufacturer CityMETTAWA IL 60045
Manufacturer CountryUS
Manufacturer Postal60045
Manufacturer G1PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.
Manufacturer StreetCERRADA V[?]A DE LA PRODUCCI[?]N 85 PARQUE UNDUSTRIAL MEX III
Manufacturer CityMEXICALI, 21397
Manufacturer CountryMX
Manufacturer Postal Code21397
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUPERNO2VA SATELLITE KIT MEDIUM
Generic NameCARDIOPULMONARY RESUSCITATION AID KIT
Product CodeOEV
Date Received2020-03-11
Model NumberSUPERNO2VA SATELLITE KIT MEDIUM
Catalog NumberSSM-20
Lot Number0004106641
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL
Manufacturer Address26125 N. RIVERWOODS BLVD. METTAWA IL 60045 US 60045


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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