MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-09 for RIFTON TRIKE R140 manufactured by Rifton Equipment.
[100020486]
Investigation incomplete pending return of the device.
Patient Sequence No: 1, Text Type: N, H10
[100020488]
It was reported that the client was using the tricycle when the bolt holding the backrest broke and the client slid backwards. The client was not hurt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319061-2018-00001 |
| MDR Report Key | 7261316 |
| Date Received | 2018-02-09 |
| Date of Report | 2018-01-11 |
| Date of Event | 2018-01-10 |
| Date Mfgr Received | 2018-01-11 |
| Device Manufacturer Date | 2006-07-22 |
| Date Added to Maude | 2018-02-09 |
| 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 | PHYSICAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TRAVIS SCOTT |
| Manufacturer Street | 103 WOODCREST DRIVE |
| Manufacturer City | RIFTON NY 12471 |
| Manufacturer Country | US |
| Manufacturer Postal | 12471 |
| Manufacturer Phone | 8456587722 |
| Manufacturer G1 | RIFTON EQUIPMENT |
| Manufacturer Street | 103 WOODCREST DRIVE |
| Manufacturer City | RIFTON NY 12471 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12471 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RIFTON TRIKE |
| Generic Name | TRICYCLE |
| Product Code | ION |
| Date Received | 2018-02-09 |
| Model Number | R140 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RIFTON EQUIPMENT |
| Manufacturer Address | 103 WOODCREST DRIVE RIFTON NY 12471 US 12471 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-09 |