MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-22 for RIFTON TRICYCLE UNKN manufactured by Rifton Equipment.
[5437962]
It was reported that a child fell off a rifton trike and got hurt.
Patient Sequence No: 1, Text Type: D, B5
[12750995]
We understand that the child was not wearing a helmet at the time of the incident. The product guide and the product labels both say that helmet use is always required when using the trike.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319061-2014-00002 |
| MDR Report Key | 4392240 |
| Report Source | 05 |
| Date Received | 2014-12-22 |
| Date of Report | 2014-12-19 |
| Date of Event | 2014-11-27 |
| Date Mfgr Received | 2014-11-24 |
| Date Added to Maude | 2015-01-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TRAVIS SCOTT |
| Manufacturer Street | 2032 RT 213 |
| Manufacturer City | RIFTON NY 12471 |
| Manufacturer Country | US |
| Manufacturer Postal | 12471 |
| Manufacturer Phone | 8456587722 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIFTON TRICYCLE |
| Generic Name | ION EXERCISER, NON-MEASURING |
| Product Code | ION |
| Date Received | 2014-12-22 |
| Model Number | UNKN |
| Catalog Number | UNKN |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RIFTON EQUIPMENT |
| Manufacturer Address | RIFTON NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-22 |