MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-24 for RIFTON TRIKE manufactured by Rifton Equipment.
[109225721]
According to the reporter, the device user was not properly supervised while using the trike. The product manual warns that a qualified professional must assess the appropriateness and safety of all equipment for each user and that adult supervision is required at all times. In addition, the reporter said that the user was not wearing a protective helmet. The product manual and product labelling warn that users should always wear a protective helmet.
Patient Sequence No: 1, Text Type: N, H10
[109225722]
It was reported that a female student was using the rifton trike. She rode too fast, turned sharply, and tipped the trike. Since she was not wearing a helmet, she hit her head, resulting in some swelling in her brain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319061-2018-00004 |
| MDR Report Key | 7542075 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-24 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-04-26 |
| Date Added to Maude | 2018-05-24 |
| 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 | 3 |
| Brand Name | RIFTON TRIKE |
| Generic Name | ADAPTIVE TRICYCLE |
| Product Code | ION |
| Date Received | 2018-05-24 |
| 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 | 2018-05-24 |