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 |