MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-09 for RIFTON R120 manufactured by Community Products Llc.
[17101155]
Our granddaughter who has had a brain tumor and stroke is somewhat limited in her walking and use of right hand. We purchased a rifton adaptive tricycle new from the manufacturer. The manual gives no warnings as to tipping of this tricycle. Our granddaughter was riding this device on a smooth paved surface (unused parking lot) and tipped over by apparently turning the wheel too sharply at some speed that allowed this to happen. Fortunately she was wearing a helmet and except for a few scrapes was ok. We called the company, rifton, and they only told us that we should provide better supervision. We have seen video of another tricycle company, tidynamic, that has installed a steering limiter on their tricycle to prevent tipping by limiting how sharply one can turn the steering wheel. Obviously rifton needs to do the same but so far is unwilling to even discuss some alternative to "better supervision".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022219 |
| MDR Report Key | 2249861 |
| Date Received | 2011-09-09 |
| Date of Report | 2011-09-09 |
| Date of Event | 2011-09-03 |
| Date Added to Maude | 2011-09-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIFTON |
| Generic Name | ADAPTIVE TRICYCLE |
| Product Code | ION |
| Date Received | 2011-09-09 |
| Model Number | R120 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMMUNITY PRODUCTS LLC |
| Manufacturer Address | PO BOX 260 RIFTON NY 12471026 US 12471 0260 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-09 |