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

Model Number SFPRO317FS-21

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 09/07/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 301483793
• Report Number: 2438477-2022-00100
• Device Sequence Number: 1
• Product Code: INI
• UDI-Device Identifier: 00822383991771
• UDI-Public: 822383991771
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• 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
• Date Report Sent to FDA: 10/10/2022
• Distributor Facility Aware Date: 09/13/2022
• Device Age: 10 MO
• Event Location: Other
• Date Report to Manufacturer: 10/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 134 KG