KIWI VACUUM DELIVERY SYSTEM VAC-6000S

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 2019-11-18 for KIWI VACUUM DELIVERY SYSTEM VAC-6000S manufactured by Clinical Innovations, Llc.

MAUDE Entry Details

Report Number1722684-2019-00018
MDR Report Key9335765
Report SourceUSER FACILITY
Date Received2019-11-18
Date of Report2019-11-05
Date of Event2019-10-07
Date Mfgr Received2019-10-11
Date Added to Maude2019-11-18
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 ContactMS. KELLIE STEFANIAK
Manufacturer Street747 W 4170 S
Manufacturer CityMURRAY UT 84123
Manufacturer CountryUS
Manufacturer Postal84123
Manufacturer Phone8012688200
Manufacturer G1CLINICAL INNOVATIONS, LLC
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 VACUUM DELIVERY SYSTEM
Generic NameFETAL VACUUM EXTRACTOR
Product CodeHDB
Date Received2019-11-18
Model NumberVAC-6000S
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCLINICAL INNOVATIONS, LLC
Manufacturer Address747 W 4170 S MURRAY UT 84123 US 84123


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-11-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.