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

Model Number	Q6 EDGE 3 STRETTO
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
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 operating the chair outside, with their wife by their side, on a rural road.They were going up a gentle slope.The wife said the sensor allegedly malfunctioned and the chair switched to manual mode.The chair allegedly began rolling back down the hill.The wife tried to stop it but due to the weight of the chair and the user, she was unable.The chair rolled down the hill and veered to the side.When the chair veered, the client allegedly fell out of the chair.
Event or Problem Description
Provider alleges the consumer was operating the chair outside, with their wife by their side, on a rural road.They were going up a gentle slope.The wife said the sensor allegedly malfunctioned and the chair switched to manual mode.The chair allegedly began rolling back down the hill.The wife tried to stop it but due to the weight of the chair and the user, she was unable.The chair rolled down the hill and veered to the side.When the chair veered, the client allegedly fell out of the chair.
Additional Manufacturer Narrative
Per provider: carried out assessment of the chair, including checking motors and brakes and seeing if anything was out of line on the chair.They deemed the chair was not damaged and was in good working condition.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: WHEELCHAIR, POWERED
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• 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: 20359007
• Report Number: 2530130-2024-00595
• Device Sequence Number: 7996257
• Product Code: ITI
• UDI-Device Identifier: 00606509200189
• UDI-Public: 00606509200189
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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 STRETTO
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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: Unknown