MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-09-20 for CARTIVA SCI manufactured by Cartiva, Inc..
| Report Number | 3009351194-2019-00018 |
| MDR Report Key | 9097565 |
| Report Source | CONSUMER |
| Date Received | 2019-09-20 |
| Date of Report | 2019-09-20 |
| Date of Event | 2019-07-16 |
| Date Mfgr Received | 2019-08-22 |
| Date Added to Maude | 2019-09-20 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TANYA EBERLE |
| Manufacturer Street | 6120 WINDWARD PARKWAY SUITE 220 |
| Manufacturer City | ALPHARETTA GA 30005 |
| Manufacturer Country | US |
| Manufacturer Postal | 30005 |
| Manufacturer Phone | 7707543814 |
| Manufacturer G1 | CARTIVA, INC. |
| Manufacturer Street | 1005 ALDERMAN DRIVE SUITE 208 |
| Manufacturer City | ALPHARETTA, |
| 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 | 2019-09-20 |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-09-20 |