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	08/12/2024
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
Alleges at the erie fairgrounds the consumer rode over an electrical cable cover on a walkway when the powerchair allegedly tipped backwards resulting in injuries.
Event or Problem Description
Alleges at the (b)(6) the consumer rode over an electrical cable cover on a walkway when the powerchair allegedly tipped backwards resulting in injuries.
Additional Manufacturer Narrative
Added additional information: serial number; device manufacture date.

• 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: 23643596
• Report Number: 2530130-2025-01062
• Device Sequence Number: 10161137
• Product Code: ITI
• UDI-Device Identifier: 00606509100311
• UDI-Public: 00606509100311
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2024
• 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