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

Model Number	SFPRO317FS-21
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a power scooter by a distributor, who stated that "the patient was on a bus," into which "the scooter was buckled in." the end user reported that the seat slid off the scooter, causing her to fall and become injured.She reported pain in her hip and a sore arm.She was taken by ambulance to the er, where she received a ct scan, was given pain killers and sent home the same day.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: 15573403
• Report Number: 2438477-2022-00100
• Device Sequence Number: 6077816
• 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 Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/13/2022
• Device Age: 10 MO
• Event Location: Other
• Date Report to Manufacturer: 10/07/2022
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 134 KG
• Date Report Sent to FDA: 10/10/2022