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

Model Number	R-TRAK
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	06/01/2026
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
Consumer's care giver alleges the wheels were spinning incessantly on unit then caught traction and got thrown down the front porch steps with user in it.Alleges the unit threw the user out of the chair onto cement pacers on the ground.They also allege they have been having issues with product ever since it was received, and dealer has either been hard to get a hold of or does not answer for weeks.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: VEHICLE MOTORIZED 3-WHEEL
• 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 18643 ; 8008008586
• MDR Report Key: 25499691
• Report Number: 2530130-2026-01294
• Device Sequence Number: 10524578
• Product Code: INI
• UDI-Device Identifier: 00606509200226
• UDI-Public: 00606509200226
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K011993
• 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
• Report Date (Section B): 06/12/2026

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: R-TRAK
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2024
• 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