MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-07 for LATITUDE ELBOW SYSTEM NOT REPORTED manufactured by Tornier Inc.
Report Number | 3004983210-2019-00124 |
MDR Report Key | 9559732 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2020-01-07 |
Date of Report | 2020-01-07 |
Date Mfgr Received | 2019-12-18 |
Date Added to Maude | 2020-01-07 |
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 46725 |
Manufacturer Country | US |
Manufacturer Postal | 46725 |
Manufacturer Phone | 5743713153 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | LATITUDE ELBOW SYSTEM |
Generic Name | LATITUDE FLEXIBLE REAMER |
Product Code | JDB |
Date Received | 2020-01-07 |
Catalog Number | NOT REPORTED |
Operator | HEALTH PROFESSIONAL |
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 55437 US 55437 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Deathisabilit | 2020-01-07 |