KIWI OMNICUP VAC-6000ME

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-05-31 for KIWI OMNICUP VAC-6000ME manufactured by Clinical Innovations.

MAUDE Entry Details

Report Number1722684-2019-00012
MDR Report Key8661101
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2019-05-31
Date of Report2019-07-16
Date of Event2019-03-27
Date Mfgr Received2019-07-15
Date Added to Maude2019-05-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS LAURA SMITH
Manufacturer Street747 W 4170 S
Manufacturer CityMURRAY UT 84123
Manufacturer CountryUS
Manufacturer Postal84123
Manufacturer Phone8012667373
Manufacturer G1CLINICAL INNOVATIONS
Manufacturer Street747 W 4170 S
Manufacturer CityMURRAY UT 84123
Manufacturer CountryUS
Manufacturer Postal Code84123
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKIWI OMNICUP
Generic NameKIWI VACUUM DELIVERY SYSTEM, OMNICUP
Product CodeHDB
Date Received2019-05-31
Returned To Mfg2019-07-09
Model NumberVAC-6000ME
Lot Number181003
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCLINICAL INNOVATIONS
Manufacturer Address747 W 4170 S MURRAY UT 84123 US 84123


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-05-31

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