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

Model Number	S710LX VICTORY 10 LX 4 WHEEL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been made available for evaluation at this time.Should the device or further information become available, a follow-up report wil then be issued.
Event or Problem Description
Alleges the brakes failed and the scooter flipped.
Additional Manufacturer Narrative
The device was returned for evaluation.The device would not stop immediately during a test ride due to a missing axle keyway in the left wheel.Based on the transaxle serial number recorded on the device history record, the transaxle was not original to the device.With this, it is likely that the wheels were removed during some unknown removal of the transaxle post final release and the keyway was not reinstalled.
Event or Problem Description
Alleges the brakes failed and the scooter flipped.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: MOTORIZED THREE-WHEELED VEHICLE
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 182 susquehanna ave; n/a; exeter PA 18643
• MDR Report Key: 6705701
• Report Number: 2530130-2017-00084
• Device Sequence Number: 11052149
• Product Code: INI
• UDI-Device Identifier: 00606509300360
• UDI-Public: 00606509300360
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

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: S710LX VICTORY 10 LX 4 WHEEL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization