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	Bone Fracture(s) (1870)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer alleges she does not feel comfortable using the unit.The speed is allegedly too fast and she allegedly injured her toe and knee.
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.
Additional Manufacturer Narrative
The unit was speed tested at highest setting and found to be within specification at 3.8 mph.
Event or Problem Description
Consumer alleges she does not feel comfortable using the unit.The speed is allegedly too fast and she allegedly injured her toe and knee.

• 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: 21901171
• Report Number: 2530130-2025-00737
• Device Sequence Number: 17198938
• Product Code: ITI
• UDI-Device Identifier: 00606509100311
• UDI-Public: 00606509100311
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/16/2025

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: JAZZY CARBON
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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: Female