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

Model Number	SC54 GO GO ELITE TRAVELLER PLUS 4 WHEEL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been available for evaluation at this time.Should the device or further information become available, a follow-up report will then be issued.
Event or Problem Description
Alleges riding scooter on the sidewalk and all of a sudden the scooter stopped.No lights on the console and would not power on.Customer alleges sliding forward and off the seat and his butt hit the foot platform.
Additional Manufacturer Narrative
The device was returned and evaluated.The evaluation concluded that the device was modified post final release.
Event or Problem Description
Alleges riding scooter on the sidewalk and all of a sudden the scooter stopped.No lights on the console and would not power on.Customer alleges sliding forward and off the seat and his butt hit the foot platform.

• 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: 6922076
• Report Number: 2530130-2017-00129
• Device Sequence Number: 10964610
• Product Code: INI
• UDI-Device Identifier: 00606509300131
• UDI-Public: 00606509300131
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K063389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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: SC54 GO GO ELITE TRAVELLER PLUS 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: 10/19/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 10/31/2017
• 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: Other