CARTIVA SCI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-09-18 for CARTIVA SCI manufactured by Cartiva, Inc..

MAUDE Entry Details

Report Number3009351194-2019-00016
MDR Report Key9083098
Report SourceHEALTH PROFESSIONAL
Date Received2019-09-18
Date of Report2019-09-18
Date of Event2019-08-16
Date Mfgr Received2019-08-19
Date Added to Maude2019-09-18
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 ContactMS. TANYA EBERLE
Manufacturer Street6120 WINDWARD PARKWAY SUITE 220
Manufacturer CityALPHARETTA 30005
Manufacturer CountryUS
Manufacturer Postal30005
Manufacturer Phone7707543814
Manufacturer G1CARTIVA, INC.
Manufacturer Street1005 ALDERMAN DRIVE SUITE 208
Manufacturer CityALPHARETTA GA 30005
Manufacturer CountryUS
Manufacturer Postal Code30005
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARTIVA SCI
Generic NameCARTIVA SCI
Product CodePNW
Date Received2019-09-18
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCARTIVA, INC.
Manufacturer Address6120 WINDWARD PARKWAY SUITE 220 ALPHARETTA GA 30022 US 30022


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-09-18

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