MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-02 for CARTIVA SCI manufactured by Wright Medical Group / Cartiva, Inc.
Report Number | MW5088744 |
MDR Report Key | 8861215 |
Date Received | 2019-08-02 |
Date of Report | 2019-07-31 |
Date of Event | 2019-02-15 |
Date Added to Maude | 2019-08-05 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | PATIENT |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | CARTIVA SCI |
Generic Name | PROSTHESIS, METATARSOPHALANGEAL JOINT, CARTILAGE REPLACEMENT IMPLANT |
Product Code | PNW |
Date Received | 2019-08-02 |
Device Availability | N |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | WRIGHT MEDICAL GROUP / CARTIVA, INC |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2019-08-02 |