MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-03-30 for AEQUALIS FLEX REVIVE ARS655101 manufactured by Tornier Inc.
| Report Number | 3004983210-2020-00012 |
| MDR Report Key | 9897202 |
| Report Source | STUDY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-30 |
| 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. MARY MCNABB |
| Manufacturer Street | 4375 E PARK 30 DRIVE |
| Manufacturer City | COLUMBIA CITY, IN |
| Manufacturer Country | US |
| Manufacturer Phone | 3713153 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AEQUALIS FLEX REVIVE |
| Generic Name | FLEX REVIVE ASSEMBLY SCREW 0MM |
| Product Code | KWS |
| Date Received | 2020-03-30 |
| Catalog Number | ARS655101 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC |
| Manufacturer Address | 10801 NESBITT AVENUE S BLOOMINGTON, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |