MAUDE Adverse Event Report: GOLDEN TECHNOLOGIES / GOLDEN BROTHERS, INC. GOLDEN LITE RIDER SCOOTER

Model Number GL 111

Device Problems Break (1069); Detachment Of Device Component (1104); Defective Component (2292)

Patient Problems Fall (1848); Head Injury (1879); Hip Fracture (2349)

Event Date 03/20/2017

Event Type  Injury  

Event Description

When descending a ramp, my 2 month-old scooter came apart and threw me onto a cement walk.(i had descended, and ascended, the same ramp in the same scooter several days earlier with no trouble.) left hip broken.Also struck head.A replacement for (b)(4) which was defective.

• Brand Name: GOLDEN LITE RIDER SCOOTER
• Type of Device: GOLDEN LITE RIDER SCOOTER
• Manufacturer (Section D): GOLDEN TECHNOLOGIES / GOLDEN BROTHERS, INC.
• MDR Report Key: 6692663
• MDR Text Key: 79522172
• Report Number: MW5070828
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: GL 111
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 88 YR
• Patient Weight: 37