MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT DRIVE DEVILBISS HEALTHCARE TRANSPORT/WHEELCHAIR; WHEELCHAIR, MECHANICAL

Model Number	SSP118FA-SF
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a wheelchair by the end user who reported that the wheelchair was difficult to open.The end user pulled the chair apart from the side arms from the front, catching her finger between the seat bar and the metal side piece.The end user cut her finger requiring four stitches.Product labeling states, "to open chair - open wheelchair by tilting to one side and pushing down on seat rail until fully opened." the end user is currently using the device.As part of its standard complaint review and evaluation process, drive devilbiss healthcare will notify the product manufacturer of this reported event.

• Brand Name: DRIVE DEVILBISS HEALTHCARE TRANSPORT/WHEELCHAIR
• Common Device Name: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT; no. 36 danyan road; danyan city, jiangsu 21230 0; CH 212300
• MDR Report Key: 23535152
• Report Number: 2438477-2025-00064
• Device Sequence Number: 21379133
• Product Code: IOR
• UDI-Device Identifier: 00822383140414
• UDI-Public: (01)00822383140414
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2025
• Report Date (Section F): 11/12/2025

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: SSP118FA-SF
• Device Catalogue Number: SSP118FA-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/28/2025
• Event Location: Home
• Date Report to Manufacturer: 11/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 11/12/2025