MAUDE Adverse Event Report: MERITS HEALTH PRODUCTS CO., LTD. MERITS; EZ-GO

Model Number	P321B
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient disassembled the power wheelchair for portability.The patient did not cover the battery connection block with the protective safety cover attached to the power wheelchair.This action left the battery connector points exposed.When the patient went to lift the scooter, their metal watch band shorted across the two battery connector points.The result was a burn to the patients wrist.The patent received non-hospitalization medical attention.

• Brand Name: MERITS
• Common Device Name: EZ-GO
• Manufacturer (Section D): MERITS HEALTH PRODUCTS CO., LTD.; 18 jingke rd., nantun dist.,; taichung city,, 40852 ; TW 40852
• Manufacturer (Section G): MERITS HEALTH PRODUCTS CO., LTD.,; 18 jingke rd., nantun dist.,; taichung city, 40852 ; TW 40852
• Manufacturer Contact: efy cheng ; 18 jingke rd., nantun dist.,; taichung city, 40852 ; TW 40852
• MDR Report Key: 23888632
• Report Number: 9680333-2025-00002
• Device Sequence Number: 11938778
• Product Code: ITI
• UDI-Device Identifier: 04714379292916
• UDI-Public: (01)04714379292916(11)211223
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2025

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: P321B
• Device Catalogue Number: P321B-SGMUB EZ-GO TUROQUOISE
• Device Lot Number: MU211200433
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown