MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL DRIVE DEVILBISS HEALTHCARE SILVER SPORT TRANSPORT/WHEELCHAIR; WHEELCHAIR, MECHANICAL

Model Number	NOR-SSP220DDA-SF
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/29/2025
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's daughter who reported that the caps from the front axle bolts detached and fell off.As a result, the exposed bolts caused the end user to sustain a leg injury.The end user required wound care, including antibiotic treatment.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 DEVILBISS HEALTHCARE SILVER SPORT TRANSPORT/WHEELCHAIR
• Common Device Name: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL; no 297,chuqiao road,; zhenjiang city, jiangsu ; CH
• MDR Report Key: 24071240
• Report Number: 2438477-2026-00003
• Device Sequence Number: 9387803
• Product Code: IOR
• UDI-Device Identifier: 00822383563312
• UDI-Public: (01)00822383563312
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/14/2026
• Report Date (Section F): 01/14/2026

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: NOR-SSP220DDA-SF
• Device Catalogue Number: NOR-SSP220DDA-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/29/2025
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2026
• 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: 01/14/2026