MAUDE Adverse Event Report: WU'S TECH CO., LTD. DRIVE MEDICAL; POWER, POV, 4 WHEEL

Model Number	SFSCOUT4
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, (b)(6) healthcare was notified of two incidents involving a scout compact power scooter.The end user called to report a "5 beep code" on the unit's battery, but also reported that the scooter has tipped over twice: once 4 years ago, when the end user drove off a small ramp, causing her to fall on her hip and resulting in a partial hip replacement; and once 2 years ago when the scooter tipped again while driving down a small ramp, causing her to fall and break her hip.Although the end user admitted that both past incidents were her fault, drive is investigating and will file an update if additional information becomes available.

• Brand Name: DRIVE MEDICAL
• Common Device Name: POWER, POV, 4 WHEEL
• Manufacturer (Section D): WU'S TECH CO., LTD.; no. 225, yuan peir st.; hsin-chu city, hsinchu ; TW
• MDR Report Key: 14023483
• Report Number: 2438477-2022-00025
• Device Sequence Number: 14966577
• Product Code: INI
• UDI-Device Identifier: 00822383519098
• UDI-Public: 822383519098
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 04/06/2022
• Report Date (Section F): 04/06/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: SFSCOUT4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 04/06/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2022
• 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; Required Intervention
• Patient Sex: Female
• Patient Weight: 52 KG
• Date Report Sent to FDA: 04/06/2022