MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-11-21 for 146-S MAPLE LEAF, SMALL manufactured by Becker Orthopedic Appliance Co.
Report Number | 1824252-2018-00002 |
MDR Report Key | 8095433 |
Report Source | COMPANY REPRESENTATIVE,USER F |
Date Received | 2018-11-21 |
Date Mfgr Received | 2018-10-23 |
Date Added to Maude | 2018-11-21 |
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 | 0 |
Initial Report to FDA | 0 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | ERICA GUICE |
Manufacturer Street | 635 EXECUTIVE DR |
Manufacturer City | TROY MI 48083 |
Manufacturer Country | US |
Manufacturer Postal | 48083 |
Manufacturer Phone | 2485887480 |
Manufacturer G1 | BECKER ORTHOPEDIC APPLIANCE CO |
Manufacturer Street | 635 EXECTUIVE DR |
Manufacturer City | TROY MI 48083 |
Manufacturer Country | US |
Manufacturer Postal Code | 48083 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | 146-S MAPLE LEAF, SMALL |
Generic Name | HIP ABDUCTION ORTHOSIS |
Product Code | ITS |
Date Received | 2018-11-21 |
Model Number | 146-S |
Catalog Number | 146-S |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BECKER ORTHOPEDIC APPLIANCE CO |
Manufacturer Address | 635 EXECTUIVE DR TROY MI 48083 US 48083 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2018-11-21 |