MAUDE Adverse Event Report: RIO MOBILITY RIO MOBILITY; DRAGONFLY MANUAL WHEELCHAIR HAND CYCLE ATTACHMENT

Model Number 8-H

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 07/29/2015

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: RIO MOBILITY
• Type of Device: DRAGONFLY MANUAL WHEELCHAIR HAND CYCLE ATTACHMENT
• Manufacturer (Section D): RIO MOBILITY; san francisco CA
• Manufacturer Contact: no.144 dong ming rd.; tajia dist.; taichung city, r.o.c. ; 426828417
• MDR Report Key: 5261448
• MDR Text Key: 32596223
• Report Number: 3004141004-2015-00001
• Device Sequence Number: 1
• Product Code: KNO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8-H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 25 YR
• Patient Weight: 54