RLV-2100 VACUUM RELIEF VALVE 4103202

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-11-22 for RLV-2100 VACUUM RELIEF VALVE 4103202 manufactured by Quest Medical, Inc.

MAUDE Entry Details

Report Number1649914-2019-00063
MDR Report Key9365903
Report SourceDISTRIBUTOR,FOREIGN
Date Received2019-11-22
Date of Report2019-11-22
Date Mfgr Received2019-10-24
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
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 NameRLV-2100 VACUUM RELIEF VALVE
Generic NameCARDIOPULMONARY SUCTION CONTROL DEVICE
Product CodeDWD
Date Received2019-11-22
Model Number4103202
Catalog Number4103202
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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