MAUDE Adverse Event Report: DONGGUAN PRESTIGE SPORTING GOODS CO LTD. DRIVE; POWER SCOOTER

Model Number	FLEX-AUTO
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abrasion (1689); Fall (1848)
Date of Event	04/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare received a complaint involving a travel scooter from an end user, who reported that while using the scooter "on paved ground" with a "minor (maybe 10-15 degree) incline on the right side," "the scooter toppled on its side on top of me." it was unclear from the report if the paved ground was uneven, with the incline on one side only, or if the paved ground had an even incline.First aid was given to the end user including lifting the scooter off of him and assisting him to his feet, as well as bandaging his right arm "from his wrist to his elbow" because it was "very scraped up." the end user also reported that he "banged [his] head on the concrete but only had a fair size bump." the end user confirmed that there was no further medical treatment besides the initial first aid, and declined to return the product for evaluation.

• Brand Name: DRIVE
• Common Device Name: POWER SCOOTER
• Manufacturer (Section D): DONGGUAN PRESTIGE SPORTING GOODS CO LTD.; 3rd industry district; qiaotou area; houjie town, dongguan guangdong 52395 0; CH 523950
• MDR Report Key: 15016214
• Report Number: 2438477-2022-00062
• Device Sequence Number: 2517413
• Product Code: INI
• UDI-Device Identifier: 00822383927350
• UDI-Public: 822383927350
• 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): 07/14/2022
• Report Date (Section F): 07/14/2022

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?: No
• Device Model Number: FLEX-AUTO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/27/2022
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2022
• 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: 102 KG
• Date Report Sent to FDA: 07/14/2022