MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD DRIVE; WHEELCHAIR

Model Number	146-K320DDA-SF
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare was notified of a complaint involving a transport wheelchair by a provider, who stated that the product "caused serious injury to user." there were no specific details provided regarding how the product caused the injury, or the injury itself.Drive is attempting to contact the end user directly to investigate the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; no.297, chuqiao road; no.39, hengtong road; zhenjiang city, jiangsu 21200 9; CH 212009
• MDR Report Key: 16844645
• Report Number: 2438477-2023-00041
• Device Sequence Number: 12484834
• Product Code: IOR
• UDI-Device Identifier: 00612479223301
• UDI-Public: 00612479223301
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2023
• Report Date (Section F): 04/28/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 146-K320DDA-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2023
• Date Report to Manufacturer: 05/05/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 04/28/2023