MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS CORPORATION PRIDE MOBILITY PRODUCTS; VEHCILE, MOTORIZED 33-WHEEL

Model Number	VICTORY 10 LX WITH CTS 4 WHEEL (S710LX
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Provider alleges the consumer was using the scooter at walmart, dismounted off the scooter to reach for a cabbage and held on to the scooter with one hand for stability and the steering column of the scooter allegedly came completely off the unit allegedly causing the consumer to fall.
Additional Manufacturer Narrative
Test drove unit.All functions perform like they should.The tiller works good and is fastened tightly.
Event or Problem Description
Provider alleges the consumer was using the scooter at walmart, dismounted off the scooter to reach for a cabbage and held on to the scooter with one hand for stability and the steering column of the scooter allegedly came completely off the unit allegedly causing the consumer to fall.
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.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: VEHCILE, MOTORIZED 33-WHEEL
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS CORPORATION; 401 york avenue; duryea PA 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york avenue; duryea, PA 18642 ; 8008008585
• MDR Report Key: 22518297
• Report Number: 2530130-2025-00852
• Device Sequence Number: 15685346
• Product Code: INI
• UDI-Device Identifier: 00606509300360
• UDI-Public: 00606509300360
• 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): 07/21/2025

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: VICTORY 10 LX WITH CTS 4 WHEEL (S710LX
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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: Female