MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; MOTORIZED THREE-WHEELED VEHICLE

Model Number	SC714 COLT EXECUTIVE
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Fracture, Arm (2351)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been evaluated at pride (b)(4) and has been found to be working safely and correctly.
Event or Problem Description
Alleges coming down slope, turned right, and then went to turn left, and the scooter suddenly increased speed considerably.Alleges turning left again to get off road, took thumb off lever but scooter kept moving and proceeded to throw customer to the ground.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: MOTORIZED THREE-WHEELED VEHICLE
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 8981389
• Report Number: 2530130-2019-00103
• Device Sequence Number: 16962744
• Product Code: INI
• UDI-Device Identifier: 00606509300322
• UDI-Public: 00606509300322
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K092088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SC714 COLT EXECUTIVE
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2019
• Initial Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization