MPS 2 CONSOLE 5201260

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 2019-11-22 for MPS 2 CONSOLE 5201260 manufactured by Quest Medical, Inc..

MAUDE Entry Details

Report Number1649914-2019-00064
MDR Report Key9365905
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-11-22
Date of Report2019-11-22
Date Mfgr Received2019-11-05
Date Added to Maude2019-11-22
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 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 NameMPS 2 CONSOLE
Generic NameCPBP HEAT EXHANGER
Product CodeDTR
Date Received2019-11-22
Model Number5201260
Lot Number3397
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerQUEST MEDICAL, INC.
Manufacturer AddressONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-22

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