MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-13 for EASYSTAND EVOLV GLIDER LARGE PNG50024 manufactured by Altimate Medical.
| Report Number | 2183634-2020-00001 |
| MDR Report Key | 9706004 |
| Report Source | CONSUMER |
| Date Received | 2020-02-13 |
| Date of Report | 2020-01-17 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2011-10-04 |
| Date Added to Maude | 2020-02-13 |
| 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 | MR. TRAVIS FLUCK |
| Manufacturer Street | 262 WEST FIRST STREET |
| Manufacturer City | MORTON, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 6976393116 |
| Manufacturer G1 | ALTIMATE MEDICAL, INC. |
| Manufacturer Street | 262 WEST FIRST STREET |
| Manufacturer City | MORTON, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASYSTAND EVOLV GLIDER LARGE |
| Generic Name | STANDING FRAME |
| Product Code | INO |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-02-04 |
| Model Number | EVOLV GLIDER LARGE |
| Catalog Number | PNG50024 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTIMATE MEDICAL |
| Manufacturer Address | 262 WEST FIRST STREET MORTON, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-13 |