MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-23 for 35-X PROFLEXX-EFNY 015710 manufactured by Ferno-washington, Inc..
[188335226]
The complainant alleges while unloading the cot from the ambulance, the cot legs allegedly failed to lower. The stretcher tilted to the side resulting in an alleged injury to a medic. No details were provided pertaining to the nature of the injury or medical intervention sought.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523574-2020-00008 |
| MDR Report Key | 9869189 |
| Report Source | OTHER |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-03-17 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2017-04-25 |
| Date Added to Maude | 2020-03-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DAWN GREENE |
| Manufacturer Street | 70 WEIL WAY |
| Manufacturer City | WILMINGTON, OH |
| Manufacturer Country | US |
| Manufacturer Phone | 2832900 |
| Manufacturer G1 | FERNO-WASHINGTON, INC. |
| Manufacturer Street | 70 WEIL WAY |
| Manufacturer City | WILMINGTON, OH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 35-X PROFLEXX-EFNY |
| Generic Name | 35-X PROFLEXX-EFNY |
| Product Code | FPO |
| Date Received | 2020-03-23 |
| Model Number | 015710 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FERNO-WASHINGTON, INC. |
| Manufacturer Address | 70 WEIL WAY WILMINGTON, OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-23 |