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

Model Number	SC710MS
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/19/2026
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
Provider alleges the consumer was at the hospital, receiving treatment in the emergency room, he left the er to go have a smoke break outside, he had some type of ointment and bandages on his skin and it's the current belief that an ash from the cigarette, or the hot part of the cigarette came into contact with his skin where the ointment/bandages were and started a fire.
Event or Problem Description
Provider alleges the consumer was at the hospital, receiving treatment in the emergency room, he left the er to go have a smoke break outside, he had some type of ointment and bandages on his skin and it's the current belief that an ash from the cigarette, or the hot part of the cigarette came into contact with his skin where the ointment/bandages were and started a fire.
Additional Manufacturer Narrative
The text and visual evidence does not suggest the unit was the cause of the alleged event.The owner's manual contains smoking warnings.

• 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 ; +1(800)800-8586
• MDR Report Key: 25572220
• Report Number: 2530130-2026-01296
• Device Sequence Number: 13005536
• Product Code: INI
• UDI-Device Identifier: 00606509300773
• UDI-Public: 00606509300773
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071949
• 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,Followup
• Report Date (Section B): 07/30/2026

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: SC710MS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• 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: 06/03/2026
• Supplement Date Received by Manufacturer: 06/03/2026; 06/03/2026
• Initial Report FDA Received Date: 06/21/2026
• Supplement Report FDA Received Date: 07/30/2026; 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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