MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-17 for CARTIVA IMPLANT 10MM manufactured by Cartiva, Inc. / Wright Medical Inc..
Report Number | MW5089870 |
MDR Report Key | 9082504 |
Date Received | 2019-09-17 |
Date of Report | 2019-09-09 |
Date of Event | 2018-12-21 |
Date Added to Maude | 2019-09-18 |
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 | 2019-09-17 |
Model Number | 10MM |
Lot Number | F052418001 |
Device Availability | * |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CARTIVA, INC. / WRIGHT MEDICAL INC. |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other; 2. Required No Informationntervention; 3. Deathisabilit | 2019-09-17 |