MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS CORPORATION PRIDE MOBILITY PRODUCTS; VECHCLE, MOTORIZED 3-WHEEL

Model Number	VICTORY LX SPORT (S710LXW)
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer alleges her scooter tipped over 3 times.The first time consumer alleges she was in a denny's parking lot and the scooter was going straight then suddenly it allegedly varied to the left & tipped over, eu jumped off the scooter trying to avoid injury and landed on her kneecap.The second time the consumer was taking out the trash (area of the terrain is uneven.Consumer was feeling this was tipping due to possibly hitting a pothole.Not sure of exact date but somewhere between (b)(6) 2025.The third time was on (b)(6) 2025 at church when she was talking to someone, and the unit allegedly varied on her causing her to tip over and allegedly she skinned her knee.
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 her scooter tipped over 3 times.The first time consumer alleges she was in a (b)(6) parking lot and the scooter was going straight then suddenly it allegedly varied to the left & tipped over, eu jumped off the scooter trying to avoid injury and landed on her kneecap.The second time the consumer was taking out the trash (area of the terrain is uneven.Consumer was feeling this was tipping due to possibly hitting a pothole.Not sure of exact date but somewhere between (b)(6) 2025.The third time was on (b)(6) 2025 at church when she was talking to someone, and the unit allegedly varied on her causing her to tip over and allegedly she skinned her knee.
Additional Manufacturer Narrative
Provider evaluated the unit and the tiller showed that is twisted to the left side seating on the scooter.Provider was able to adjust the shaft to straighten the front tire, so it can line up with tiller.Scooter is working properly and consumer is satisfied.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: VECHCLE, MOTORIZED 3-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 18462 ; 8008008586
• MDR Report Key: 21695974
• Report Number: 2530130-2025-00773
• Device Sequence Number: 9308114
• Product Code: INI
• UDI-Device Identifier: 00606509300438
• UDI-Public: 00606509300438
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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): 01/20/2026

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: VICTORY LX SPORT (S710LXW)
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2024
• 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: Female