MAUDE Adverse Event Report: MERITS HEALTH PRODUCTS CO., LTD. MERITS; VISION SUPER

Model Number	P327
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer states the unit seat became unlatched and went forward while driving, upon further inspection, the clamp in the back was not locked in.
Additional Manufacturer Narrative
The device is currently unavailable for evaluation.A follow-up report will be issued if additional information or the device itself becomes available.

• Brand Name: MERITS
• Common Device Name: VISION SUPER
• 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: 22737669
• Report Number: 9680333-2025-00001
• Device Sequence Number: 18417974
• Product Code: ITI
• UDI-Device Identifier: 04714379298550
• UDI-Public: (01)04714379298550(11)240531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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
• Device Model Number: P327
• Device Catalogue Number: P3278-ARMUB SUPER P327 RED
• Device Lot Number: MU240502759
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2024
• 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