BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERITS

    MDR report key: 23888632 · Received December 24, 2025

    Report

    Report Number
    9680333-2025-00002
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 1, 2025
    Manufacturer
    MERITS HEALTH PRODUCTS CO., LTD.
    Product Code
    ITI
    UDI-DI
    04714379292916
    PMA / PMN Number
    K011687
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058061 MERITS EZ-GO ITI MERITS HEALTH PRODUCTS CO., LTD. P321B MU211200433 04714379292916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention