MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO. DRIVE DEVILBISS HEALTHCARE; WHEELCHAIR, MECHANICAL

Model Number	K318DFA-SF
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident allegedly involving a wheelchair by a letter from an attorney, which states the end user was using the wheelchair without the legrests when her foot came into contact with the edge of the fork on the wheel, resulting in a laceration to her foot that required 25 stitches.The end user was prescribed antibiotics.The end user was later admitted to the hospital with hematoma to the wound, which required two surgical procedures and wound care.Drive devilbiss healthcare is currently investigating the incident, including attempting to inspect the device in cooperation with the attorney.
Additional Manufacturer Narrative
Drive devilbiss healthcare recieved the serial number to the device.Serial number (b)(6) as well as the manufacturer.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO.; no.297 chuquiao road; zhenjiang, jiangsu ; CH
• MDR Report Key: 19082199
• Report Number: 2438477-2024-00018
• Device Sequence Number: 7759723
• Product Code: IOR
• UDI-Device Identifier: 00822383133874
• UDI-Public: 822383133874
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 06/26/2024
• Report Date (Section F): 06/26/2024

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
• Device Model Number: K318DFA-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/26/2024
• Event Location: Home
• Date Report to Manufacturer: 06/26/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 06/26/2024
• 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: Hospitalization
• Patient Sex: Female
• Date Report Sent to FDA: 06/26/2024