MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-10-21 for RIO MOBILITY 8-H manufactured by Rio Mobility.
[32596223]
Based on the information provided by the complainant (b)(4) determined the dragonfly did not fail and decided not to have the user return it for testing. (b)(4) was able to simulate the event using a dragonfly from stock. Test 1: tested the dragonfly outside and recreated the event described by the complaint. When loosing control of the dragonfly, we were able to regain it again by letting the dragonfly roll back and naturally swerve to the right and engaging the secondary brake located in front of the dragonfly. Test 2: assessed the entire dragonfly and simulated a hand slipping between the chain and sprocket guard. We determined the spot between the chain and sprocket guard is a pinch point and should either be covered or labeled as a pinch point. Conclusion: it has been concluded the combination of the following resulted in the user's injury: user error, pinch point between the dragonfly chain and sprocket guard and context of the event.
Patient Sequence No: 1, Text Type: N, H10
[32596226]
Complainant emailed (b)(4) to report his husband (user) was injured while using the dragonfly for the first time. The complainant stated the user came to a complete stop on a hill to shift gears then proceeded to lose control of the dragonfly. The user panicked and tried to regain control by attempting to grab the pedals. In the process of trying to regain control, the user grabbed the sprocket guard with his right hand and his right index finger was pinched between the sprocket guard and chain resulting in a broken tendon and tore up skin. Complainant indicated in a phone conversation and in an email that the user elected not to have surgery due to the fact that he is a full time wheelchair user and the recovery time is too long. Ref# mw5055545.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004141004-2015-00001 |
| MDR Report Key | 5261448 |
| Report Source | CONSUMER |
| Date Received | 2015-10-21 |
| Date of Report | 2015-08-03 |
| Date of Event | 2015-07-29 |
| Date Mfgr Received | 2015-03-26 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2015-12-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | NO.144 DONG MING RD. TAJIA DIST. |
| Manufacturer City | TAICHUNG CITY, R.O.C. |
| Manufacturer Country | TW |
| Manufacturer Phone | 426828417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RIO MOBILITY |
| Generic Name | DRAGONFLY MANUAL WHEELCHAIR HAND CYCLE ATTACHMENT |
| Product Code | KNO |
| Date Received | 2015-10-21 |
| Model Number | 8-H |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RIO MOBILITY |
| Manufacturer Address | SAN FRANCISCO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-10-21 |