MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-02 for CARTIVA IMPLANT manufactured by Wright Medical/cartiva, Inc..
Report Number | MW5088739 |
MDR Report Key | 8861114 |
Date Received | 2019-08-02 |
Date of Report | 2019-07-31 |
Date of Event | 2018-06-04 |
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 IMPLANT |
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/CARTIVA, INC. |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-08-02 |