MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-26 for 35-P PROFLEXX 0015614 manufactured by Ferno-washington, Inc..
[188334476]
The device was evaluated by an authorized repair technician. No issues were found that would have allowed the cot to tip on its side unexpectedly. The ifu provides proper instructions for safe unloading of the cot from the ambulance. No further details were provided pertaining to the alleged patient injury.
Patient Sequence No: 1, Text Type: N, H10
[188334477]
The complainant reported while unloading a patient from the ambulance, the cot allegedly tipped over. The patient allegedly sustained a laceration to the toe, as a result. Medical intervention was conducted to control bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523574-2020-00006 |
| MDR Report Key | 9758121 |
| Report Source | OTHER |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2003-07-09 |
| Date Added to Maude | 2020-02-26 |
| 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-P PROFLEXX |
| Generic Name | 35-P PROFLEXX |
| Product Code | FPO |
| Date Received | 2020-02-26 |
| Model Number | 0015614 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-26 |