MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT DRIVE SILVER SPORT 2 WHEELCHAIR; WHEELCHAIR, MECHANICAL

Model Number	SSP216DDA-SF
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/13/2025
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 stated that while moving from a toilet seat to the wheelchair, a sharp protruding plate on the wheelchair caused a laceration on the end user's left leg that is being treated with a skin graft.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: DRIVE SILVER SPORT 2 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: 22002277
• Report Number: 2438477-2025-00024
• Device Sequence Number: 7109483
• Product Code: IOR
• UDI-Device Identifier: 00822383145280
• UDI-Public: (01)00822383145280
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/12/2025
• Report Date (Section F): 05/12/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SSP216DDA-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/16/2025
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 05/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2025
• 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 Age: 83 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/12/2025