MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-19 for MAPLE LEAF 146-S manufactured by Becker Orthopedic Appliance Co..
[124343459]
Pressure ulcer developed on the posterior right leg located under the brace. Back of the brace was noted to be hard and applied pressure to the thigh.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7983914 |
| MDR Report Key | 7983914 |
| Date Received | 2018-10-19 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-10-03 |
| Report Date | 2018-10-12 |
| Date Reported to FDA | 2018-10-12 |
| Date Reported to Mfgr | 2018-10-19 |
| Date Added to Maude | 2018-10-19 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | MAPLE LEAF |
| Generic Name | JOINT, HIP, EXTERNAL BRACE |
| Product Code | ITS |
| Date Received | 2018-10-19 |
| Model Number | 146-S |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKER ORTHOPEDIC APPLIANCE CO. |
| Manufacturer Address | 635 EXECUTIVE DRIVE TROY MI 48083 US 48083 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-19 |