MAUDE Adverse Event Report: LERADO ZHONGSHAN PEACEFUL COVE BUSINESS DRIVE; POWER MOBILITY

Model Number	SFPRO317FS-21
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a scooter.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.We will submit a follow up when additional data becomes available.The user noted that her scooter's back end was "rocking".In consultation with our tech department we recommended replacement.Before the replacement was executed the user rode the device, fell off, hit her head, and received medical attention at the hospital.They are requesting a 4 wheel unit to replace the 3-wheeled damaged device.No additional information is available.

• Brand Name: DRIVE
• Common Device Name: POWER MOBILITY
• Manufacturer (Section D): LERADO ZHONGSHAN PEACEFUL COVE BUSINESS; no.26, guangfu road; dong sheng town; zhongshan, guangdong 52841 4; CH 528414
• MDR Report Key: 12828955
• Report Number: 2438477-2021-00072
• Device Sequence Number: 4364823
• Product Code: INI
• UDI-Device Identifier: 00822383991771
• UDI-Public: 822383991771
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/11/2021
• Report Date (Section F): 11/17/2021

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 the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/25/2021
• Device Age: 3 MO
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2021
• 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: 11/17/2021