MAUDE Adverse Event Report: LERADO H.K. LIMITED DRIVE DEVILBISS HEALTHCARE; VEHICLE, MOTORIZED 3-WHEELED

Model Number	SFPRO317FS-21
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	12/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident by the provider that an end user was using a motorized scooter in a parking lot when the device went over a "concave" bump and the entire unit fell over.The end user's leg was scratched/cut.The wounds became infected and the user was admitted to the hospital for cellulitis.The device is being returned for evaluation.An update will be filed if additional information becomes available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: VEHICLE, MOTORIZED 3-WHEELED
• Manufacturer (Section D): LERADO H.K. LIMITED; rm f&g 4/f golden sun ctr; 59-67 bonham strand; w sheung wan, hong kong ; HK
• MDR Report Key: 18758653
• Report Number: 2438477-2024-00009
• Device Sequence Number: 3729428
• Product Code: INI
• UDI-Device Identifier: 00822383991771
• UDI-Public: 822383991771
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/22/2024
• Report Date (Section F): 02/22/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: SFPRO317FS-21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/29/2024
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/22/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2024
• 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: Male
• Date Report Sent to FDA: 02/22/2024