MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-09-25 for CARTIVA SCI manufactured by Cartiva, Inc..
Report Number | 3009351194-2019-00020 |
MDR Report Key | 9117113 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2019-09-25 |
Date Mfgr Received | 2019-08-26 |
Date Added to Maude | 2019-09-25 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. TANYA EBERLE |
Manufacturer Street | 6120 WINDWARD PARKWAY SUITE 220 |
Manufacturer City | ALPHARETTA GA 30022 |
Manufacturer Country | US |
Manufacturer Postal | 30022 |
Manufacturer Phone | 7707543814 |
Manufacturer G1 | CARTIVA, INC. |
Manufacturer Street | 1005 ALDERMAN DRIVE SUITE 208 |
Manufacturer City | ALPHARETTA GA 30005 |
Manufacturer Country | US |
Manufacturer Postal Code | 30005 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CARTIVA SCI |
Generic Name | CARTIVA SCI |
Product Code | PNW |
Date Received | 2019-09-25 |
Device Availability | * |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CARTIVA, INC. |
Manufacturer Address | 6120 WINDWARD PARKWAY SUITE 220 ALPHARETTA GA 30005 US 30005 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-09-25 |