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

Model Number	JAZZY EVO614HD
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	05/20/2025
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 alleges the driver of bus pushed him on and off bus but when he did the driver hit the seat of the unit on the seats on the bus and that is when the damange initally occurred.Seat will not stay in place [?] tech came down to check unit.Consumer had rope tied to seat to keep it in position and when tech took it off he allegedly did not put it on tight the consumer ran into towel rack and a furnace.
Additional Manufacturer Narrative
The seat was mated with the base and the seat handle would not engage with the clover leaf on the seat post causing the seat to rotate freely.The evidence of paint on the handle and text indicating the damage occurred on a bus would appear to indicate the seat/post interface was compromised.
Event or Problem Description
Consumer alleges the driver of bus pushed him on and off bus but when he did the driver hit the seat of the unit on the seats on the bus and that is when the damange initally occurred.Seat will not stay in place [?] tech came down to check unit.Consumer had rope tied to seat to keep it in position and when tech took it off he allegedly did not put it on tight the consumer ran into towel rack and a furnace.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: WHEELCHAIR, POWERED
• 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 18643 ; 8008008586
• MDR Report Key: 22578197
• Report Number: 2530130-2025-00911
• Device Sequence Number: 9237706
• Product Code: ITI
• UDI-Device Identifier: 00606509100304
• UDI-Public: 00606509100304
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042612
• 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): 01/30/2026

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: JAZZY EVO614HD
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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: Male