MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-30 for 35-X PROFLEXX-EFNY 0015710 manufactured by Ferno-washington, Inc..
[188336717]
The complainant reported while transporting a patient on the cot which was locked in the fastening device, the cot allegedly became dislodged allowing the cot to strike the medic's bench seat. The patient alleged injury, but no further details have been provided pertaining to the alleged injury and/or medical intervention sought.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523574-2020-00005 |
| MDR Report Key | 9649415 |
| Report Source | OTHER |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2017-05-24 |
| Date Added to Maude | 2020-01-30 |
| 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 45177 |
| Manufacturer Country | US |
| Manufacturer Postal | 45177 |
| Manufacturer Phone | 9372832900 |
| Manufacturer G1 | FERNO-WASHINGTON, INC. |
| Manufacturer Street | 70 WEIL WAY |
| Manufacturer City | WILMINGTON OH 45177 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45177 |
| 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 | 2020-01-30 |
| Model Number | 0015710 |
| 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 45177 US 45177 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-30 |