MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS CORPORATION PRIDE MOBILITY PRODUCTS; WHEELCHAIR, POWERED

Model Number	Q6 EDGE 3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer's mother alleges her daughter was in the chair and it allegedly drove on its own and ran into a bookcase.She was allegedly thrown to the ground and the bookcase fell on top of her.
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 mother alleges her daughter was in the chair and it allegedly drove on its own and ran into a bookcase.She was allegedly thrown to the ground and the bookcase fell on top of her.
Additional Manufacturer Narrative
On 10/30/2025 rep evaluated unit in the field.They have come to the conclusion that this was more than likely self-inflicted.Dad was moving the entire joystick assemble around when the accident occurred.It is believed he pivoted it back and the arm pad hit the joystick knob and caused the chair to lurch forward.I looked over the entire chair.I adjusted the joystick and remounted it.I test drove the chair as well.Everything is functioning as intended.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: WHEELCHAIR, POWERED
• 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 18642 ; 8008008586
• MDR Report Key: 23616201
• Report Number: 2530130-2025-01055
• Device Sequence Number: 18653244
• Product Code: ITI
• UDI-Device Identifier: 00606509200158
• UDI-Public: 00606509200158
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K143383
• 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): 01/16/2026

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: Q6 EDGE 3
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2024
• 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