MAUDE Adverse Event Report: ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD Pride Mobility Products; Wheelchair, Powered

Model Number	Jazzy Carbon
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer's wife alleges her husband was allegedly going up a slope and the chair allegedly tipped backwards.
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 wife alleges her husband was allegedly going up a slope and the chair allegedly tipped backwards.
Additional Manufacturer Narrative
Our research shows the chair was used to climb a slope well outside what it's rated for and unfortunately the tip over occurred.Updated production date.

• Brand Name: Pride Mobility Products
• Common Device Name: Wheelchair, Powered
• Manufacturer (Section D): ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD; add.: no.196 industry road, he; dongyang, zhejiang ; CH
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: maggie lyu ; no.196 industry road, hengdian movie zone,; dongyang, zhejiang ; CH
• MDR Report Key: 23083749
• Report Number: 2530130-2025-00984
• Device Sequence Number: 4749132
• Product Code: ITI
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K220747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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 Carbon
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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: Unknown