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	Abrasion (1689)
Date of Event	01/11/2026
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 that when he is exiting the train the "lightrail" at one stop by his home it is not level.The platform is higher than the train allegedly causing his unit to tip over with him in in several times.
Event or Problem Description
Consumer alleges that when he is exiting the train the "lightrail" at one stop by his home it is not level.The platform is higher than the train allegedly causing his unit to tip over with him in in several times.
Additional Manufacturer Narrative
Tech sent as a courtesy.On 03/20/2026 tech went out to evaluate unit.Per tech: checked for damage on chair.Everything is in working order.Anti tippers are working as intended.No damage to anti - tippers.Unit working properly.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: WHEELCHAIR, POWERED
• Manufacturer (Section D): ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD; 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: 24144138
• Report Number: 2530130-2026-01107
• Device Sequence Number: 8969199
• Product Code: ITI
• UDI-Device Identifier: 00606509100311
• UDI-Public: 00606509100311
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K220747
• 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): 03/26/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2024
• 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