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	Abrasion (1689)
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer alleges she does not believe she has the appropriate seating system for her unit and feels that she may require a different seat.She alleges that the current seat causes her to slide forward, preventing her from maintaining proper back support against the seat back.As a result, she alleges that she is experiencing back pain and that the sliding is contributing to pressure sores.
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.

• 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 18643 ; +1(800)800-8586
• MDR Report Key: 50155829
• Report Number: 2530130-2026-01374
• Device Sequence Number: 13405940
• Product Code: ITI
• UDI-Device Identifier: 00606509100304
• UDI-Public: 00606509100304
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K042612
• 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
• Report Date (Section B): 08/06/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2022
• 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