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	09/13/2025
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 she was at a wedding when going through the bathroom door she's unsure if she went too fast or the chair allegedly lurched forward, which she alleges it does sometimes and her outstretched foot (to help open the door) went up a wall that was right inside the door.The chair allegedly proceeded to go up the wall as well until it tipped over backwards and she hit her head on the cement floor.
Additional Manufacturer Narrative
Tech went out and on 11/12/2025.The evaluation of (b)(6) jazzy is complete.To sum up our tech's findings, it looks like at the time of the incident the anti-tippers on her power chair were not extended while attempting to move through a door that was not handicapped accessible.Tech made sure they were fully extended and then educated the customer on keeping her power chair on flat surfaces to prevent future tips and falls.There's no damage noted to her jazzy carbon chair.Updated the "date received by manufacturer".
Event or Problem Description
Consumer alleges she was at a wedding, when going through the bathroom door, she's unsure if she went too fast or the chair allegedly lurched forward, which she alleges it does sometimes and her outstretched foot (to help open the door) went up a wall that was right inside the door.The chair allegedly proceeded to go up the wall as well until it tipped over backwards and she hit her head on the cement floor.

• 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: 23367413
• Report Number: 2530130-2025-01015
• Device Sequence Number: 13041239
• Product Code: ITI
• UDI-Device Identifier: 00606509100311
• UDI-Public: 00606509100311
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/08/2026

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: 09/13/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2023
• 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