MAUDE Adverse Event Report: GOLDEN TECHNOLOGIES, INC. / GOLDEN BROTHERS, INC. 4 WHEEL SCOOTER; VEHICLE, MOTORIZED 3-WHEELED

Model Number GA541

Device Problems Break (1069); Protective Measures Problem (3015); Noise, Audible (3273)

Patient Problems Pain (1994); Unspecified Tissue Injury (4559)

Event Date 08/19/2021

Event Type  Injury  

Event Description

Caller stated early this year when he pushed his 4-wheel scooter to go forward it gets a clicking sound and then the scooter goes into full reverse.He tried stopping it on this day using the paddle control but it did not stop.He contacted the manufacturer and was asked to return the device for repairs.After three with the manufacturer the scooter was returned back to the caller but the problem persist.A new controller and paddle was sent to the caller and installed into the scooter, but the scooter still did not work correctly.Yesterday (b)(6) 2021 caller stated that he was driving the scooter and the same problem happened but this time he was thrown off the scooter where he sustained injuries all over his body and experienced pain.The scooter is now damaged that he could not turn it to the left or right.

• Brand Name: 4 WHEEL SCOOTER
• Type of Device: VEHICLE, MOTORIZED 3-WHEELED
• Manufacturer (Section D): GOLDEN TECHNOLOGIES, INC. / GOLDEN BROTHERS, INC.
• MDR Report Key: 12354143
• MDR Text Key: 268209444
• Report Number: MW5103416
• Device Sequence Number: 1
• Product Code: INI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GA541
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 195