RIO MOBILITY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-14 for RIO MOBILITY manufactured by Rio Mobility.

Event Text Entries

[23752727] My husband and i were out for a ride with his new rio mobility dragonfly handcycle. We arrived upon a hill and it was hard for him to continue up the hill and he came to a stop, he went to shift down a few gears, but started rolling backwards and panicked. When he reached for the hand grip on the right side his right index finger got pinched in-between the bike chain and the top crank-gear (much like the primary gear on a regular bicycle). Fortunately he did not break any bones in his finger, however he did break a tendon and tore up the skin on his finger pretty badly, and required a trip to the emergency room and will need surgery for the tendon. This could have been prevented if they had a better safety cover over the chain and crank gear mechanism. I feel this only happened because he panicked, but could definitely happen in the future. I am also going to contact the mfr directly. Injury info: injury, emergency department treatment received. (b)(4). Purchase date: (b)(6) 2015. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5055545
• MDR Report Key: 5018300
• Date Received: 2015-08-14
• Date of Report: 2015-08-03
• Date of Event: 2015-07-29
• Date Added to Maude: 2015-08-20
• 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: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: RIO MOBILITY
• Generic Name: CYCLING, SCOOTERS, SKATEBOARDS & SKATES
• Product Code: KNO
• Date Received: 2015-08-14
• Device Availability: *
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RIO MOBILITY
• Manufacturer Address: 2325 3RD STREET, STE 242 SAN FRANCISCO CA 94107 US 94107

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-08-14