MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD DRIVEMEDICAL; WHEELCHAIR, MECHANICAL, PRODUCT CODE: IOR

Model Number	CX418ADDA-ELR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Laceration(s) (1946); Concussion (2192); Convulsion/Seizure (4406)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a wheelchair by the provider who stated the end user was sitting in the wheelchair and a wheel broke causing the end user to fall to the floor.The end user was hospitalized with a concussion, seizures, and a forearm skin tear.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVEMEDICAL
• Common Device Name: WHEELCHAIR, MECHANICAL, PRODUCT CODE: IOR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; no.297/799, chuqiao road; no.39, hengtong road; zhenjiang, jiangsu 21200 9; CH 212009
• Manufacturer (Section G): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; no.297/799, chuqiao road; no.39, hengtong road; zhenjiang, jiangsu 21200 9; CH 212009
• Manufacturer Contact: ying mei ; no.297/799, chuqiao road; no.39, hengtong road; zhenjiang, jiangsu 21200-9 ; CH 212009
• MDR Report Key: 23387834
• Report Number: 3007309323-2025-00056
• Device Sequence Number: 14681489
• Product Code: IOR
• UDI-Device Identifier: 00822383528335
• UDI-Public: (01)00822383528335
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Remedial Action: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: CX418ADDA-ELR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 10/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Patient Weight: 65 KG