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

Model Number	GO GO ES 2 3 WHEEL (S81)
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	10/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer's daughter alleges while her mother was shopping, the steering wheel column allegedly collapsed onto her lap and the accelerator button pressed against her lap causing the unit to still accelerate allegedly causing her mom to crash into a display case.
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.
Additional Manufacturer Narrative
Customer abuse-the tiller knob used to tighten the tiller was fractured post final release.(unit passed final release inspection and test ride in 2023) the fractured knob was readily apparent.
Event or Problem Description
Consumer's daughter alleges while her mother was shopping the steering wheel column allegedly collapsed onto her lap and the accelerator button pressed against her lap causing the unit to still accelerate allegedly causing her mom to crash into a display case.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: VEHICLE, MOTORIZED 3-WHEELED
• 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 18462 ; 8008008586
• MDR Report Key: 22282443
• Report Number: 2530130-2025-00866
• Device Sequence Number: 12994288
• Product Code: INI
• UDI-Device Identifier: 00606509300148
• UDI-Public: 00606509300148
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090524
• 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): 02/04/2026

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 ES 2 3 WHEEL (S81)
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2023
• 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