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

Model Number	SC709 VICTORY 9 4 WHEEL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been available for evaluation at this time.Should further information or the device become available, a follow-up report will then be issued.
Event or Problem Description
Consumer alleges while crossing a street she saw a car coming that she didn't believe was going to stop.She allegedly adjusted the speed control and the scooter allegedly took off and she allegedly hit her toe against a (b)(6) building.
Event or Problem Description
Consumer alleges while crossing a street she saw a car coming that she didn't believe was going to stop.She allegedly adjusted the speed control and the scooter allegedly took off and she allegedly hit her toe against a cvs pharmacy building.
Additional Manufacturer Narrative
The device was evaluated by a field service technician.The fst tightened the knob on tiller.The unit is working properly.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: MOTORIZED THREE WHEELED VEHICLE
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea, pa
• MDR Report Key: 10065843
• Report Number: 2530130-2020-00049
• Device Sequence Number: 10932395
• Product Code: INI
• UDI-Device Identifier: 00606509300384
• UDI-Public: 00606509300384
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: SC709 VICTORY 9 4 WHEEL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 07/02/2020
• 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