MAUDE Adverse Event Report: ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTDZHEJIANG INNUOVO REHABILITATION; WHEELCHAIR, POWERED

Model Number	JAZZY CARBON
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	06/10/2024
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
Provider alleges the consumer alleges he was unaware the armrest had cracked, and when he had gone to get up out of the chair, he had leaned on the armrest.Due to the crack in the armrest, it would not support his weight allegedly causing him to fall getting out of the chair.
Additional Manufacturer Narrative
Failure to head product warnings.Updated the "device manufacturer date".
Event or Problem Description
Provider alleges the consumer alleges he was unaware the armrest had cracked, and when he had gone to get up out of the chair, he had leaned on the armrest.Due to the crack in the armrest, it would not support his weight allegedly causing him to fall getting out of the chair.
Event or Problem Description
Provider alleges the consumer alleges he was unaware the armrest had cracked, and when he had gone to get up out of the chair, he had leaned on the armrest.Due to the crack in the armrest, it would not support his weight allegedly causing him to fall getting out of the chair.
Additional Manufacturer Narrative
Correction of the manufacturer.Additional information.

• Brand Name: ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTDZHEJIANG INNUOVO REHABILITATION
• Common Device Name: WHEELCHAIR, POWERED
• Manufacturer (Section D): ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTD; no.196 industry road, hengdian; dongyang, zhejiang ; CH
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: maggie lyu ; no.196 industry road, hengdian; dongyant, zhejiang ; CH
• MDR Report Key: 19827029
• Report Number: 2530130-2024-00495
• Device Sequence Number: 8709528
• Product Code: ITI
• UDI-Device Identifier: 00606509100311
• UDI-Public: 00606509100311
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2024

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: 07/09/2024
• Supplement Date Received by Manufacturer: 07/09/2024; 07/09/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/08/2024; 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2023
• 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: Male