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

Model Number	SFPRO317FS-21
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a power scooter by an end user who stated that just after he had "adjusted the seat as it was too high," he was being transported and "the seat slid completely off the scooter body." it is unclear how the end user was being transported.The end user reportedly sustained injuries to his shoulder and aggravated an already bad hip as a result of the incident, and sought treatment in the emergency room.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: 16887076
• Report Number: 2438477-2022-00145
• Device Sequence Number: 6326749
• Product Code: INI
• UDI-Device Identifier: 00822383991771
• UDI-Public: 00822383991771
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2023
• Report Date (Section F): 05/08/2023

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
• 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: 09/08/2022
• Date Report to Manufacturer: 05/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 134 KG
• Date Report Sent to FDA: 05/08/2023