MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS CORPORATION PRIDE MOBILITY PRODUCTS; VEHICLE, MOTORIZED 3-WHEELED

Model Number	REVO 2.0 4 WHEEL (S67)
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.Should further information or the device become available, a follow-up report will then be issued.
Event or Problem Description
Provider alleges consumer was crossing the road and the scooter allegedly cut out on her.When it started again she was near the curb cut out and the scooter allegedly jolted and threw her off and flipped over on her.
Event or Problem Description
Provider alleges consumer was crossing the road and the scooter allegedly cut out on her.When it started again; she was near the curb cut out and the scooter allegedly jolted and threw her off and flipped over on her.
Additional Manufacturer Narrative
This issue was caused from the dealer installing 3rd party batteries and the lock washers missing on the left battery.This caused the screws to buttom out causing a gap between the screw and battery.As per the consumer safety guide battery replacement should follow the below guidelines: per the information for use manual: warning! only spill-proof sealed batteries, such as "gelled electrolyte," that meet dot cfr 173.159 should be used in the scooter.Replacement batteries should be obtained directly from an authorized provider to ensure conformity, fit, and function.Updated manufacturer date.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: VEHICLE, MOTORIZED 3-WHEELED
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS CORPORATION; 401 york avenue; duryea PA 18643
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york avenue; duryea, PA 18642 ; 8008008586
• MDR Report Key: 23255015
• Report Number: 2530130-2025-01002
• Device Sequence Number: 13303965
• Product Code: INI
• UDI-Device Identifier: 00606509300247
• UDI-Public: 00606509300247
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: REVO 2.0 4 WHEEL (S67)
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female