MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS CORPORATION Pride Mobility Products; Vehicle, Motorized 3-Wheeled

Model Number	Go Go Endurance LI (S54LXLIT)
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	10/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer alleges he was on paved path of botanical gardens, stopped on incline and when started to go forward the scooter allegedly flipped over on him.
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
Consumer alleges he was on paved path of botanical gardens, stopped on incline and when started to go forward the scooter allegedly flipped over on him.
Additional Manufacturer Narrative
On 11/13/2025 tech replaced transaxle and unit is working properly.Parts were not received back for evaluation.

• 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 ; +1(800)800-8586
• MDR Report Key: 23310067
• Report Number: 2530130-2025-01008
• Device Sequence Number: 14736316
• Product Code: INI
• UDI-Device Identifier: 00606509300575
• UDI-Public: 00606509300575
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: Go Go Endurance LI (S54LXLIT)
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2024
• 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: Male