MAUDE Adverse Event Report: LERADO H.K. LTD. DRIVE; POWER SCOOTER

Model Number	SFPRO317FS-21
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a power scooter by an end user's sister, who stated that the end user "tried to get onto the scooter and must have tried to hold on by the throttle and it moved on her," causing her to fall and injure her leg.She was reportedly hospitalized for 3 days and is now undergoing physical therapy.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: POWER SCOOTER
• Manufacturer (Section D): LERADO H.K. LTD.; 22/f the wellington; 198 wellington street central; hong kong, xinjiang ; CH
• MDR Report Key: 15574262
• Report Number: 2438477-2022-00105
• Device Sequence Number: 2780886
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2022
• Report Date (Section F): 10/10/2022

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
• Device Model Number: SFPRO317FS-21
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/12/2022
• Device Age: 10 MO
• Event Location: Home
• Date Report to Manufacturer: 10/17/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 10/10/2022