RETROGUARD ARTERIAL SAFETY VALVE 4007200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-07-12 for RETROGUARD ARTERIAL SAFETY VALVE 4007200 manufactured by Quest Medical, Inc.

MAUDE Entry Details

Report Number1649914-2019-00032
MDR Report Key8787006
Report SourceUSER FACILITY
Date Received2019-07-12
Date of Report2019-07-12
Date of Event2019-06-19
Date Mfgr Received2019-06-19
Date Added to Maude2019-07-12
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 ContactTOSAN ONOSODE
Manufacturer StreetONE ALLENTOWN PARKWAY
Manufacturer CityALLEN TX 75002
Manufacturer CountryUS
Manufacturer Postal75002
Manufacturer Phone9723326338
Manufacturer G1QUEST MEDICAL, INC
Manufacturer StreetONE ALLENTOWN PARKWAY
Manufacturer CityALLEN TX 75002
Manufacturer CountryUS
Manufacturer Postal Code75002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRETROGUARD ARTERIAL SAFETY VALVE
Generic NameCPB CHECK VALVE
Product CodeMJJ
Date Received2019-07-12
Model Number4007200
Catalog Number4007200
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerQUEST MEDICAL, INC
Manufacturer AddressONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-12

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