2500CC CANISTER V71-1107

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 2020-03-18 for 2500CC CANISTER V71-1107 manufactured by Deroyal Industries, Inc..

MAUDE Entry Details

Report Number1057404-2020-00001
MDR Report Key9848215
Report SourceUSER FACILITY
Date Received2020-03-18
Date of Report2020-03-18
Date of Event2020-02-20
Date Mfgr Received2020-03-18
Date Added to Maude2020-03-18
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 ContactSARAH BENNETT
Manufacturer Street200 DEBUSK LANE
Manufacturer CityPOWELL, TN
Manufacturer CountryUS
Manufacturer Phone3626112
Manufacturer G1DEROYAL INDUSTRIES, INC.
Manufacturer Street300 DEBUSK LANE
Manufacturer CityPOWELL, TN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name2500CC CANISTER
Generic NameBOTTLE, COLLECTION, VACUUM
Product CodeKDQ
Date Received2020-03-18
Returned To Mfg2020-02-28
Model NumberV71-1107
Lot NumberNOT PROVIDED
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEROYAL INDUSTRIES, INC.
Manufacturer Address300 DEBUSK LANE POWELL, TN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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