BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALA KIQ

    MDR report key: 22288053 · Received June 18, 2025

    Report

    Report Number
    3011628389-2025-00001
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    May 20, 2025
    Report Date
    June 18, 2025
    Manufacturer
    CALA HEALTH INC
    Product Code
    QBC
    UDI-DI
    00851749007412
    PMA / PMN Number
    K222237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    A HEALTHCARE PROVIDER'S OFFICE REPORTED THAT A PATIENT WAS HOSPITALIZED WITH AFIB REQUIRING A CARDIOVERSION AFTER USING THE DEVICE. THE PATIENT STOPPED USING THE DEVICE DUE TO THIS ISSUE. THE PATIENT'S SPOUSE REPORTED A HISTORY OF AFIB AND UNCERTAINTY ABOUT WHETHER THE RECENT EPISODE WAS CAUSED BY DEVICE USAGE. INITIALLY, THE PATIENT USED THE DEVICE REGULARLY WITHOUT ISSUE AND WISHED TO CONTINUE USE DUE TO FAVORABLE RESULTS WITH THE THERAPY, PENDING THE HEALTHCARE PROVIDER'S RECOMMENDATION. THE HEALTHCARE PROVIDER SUBSEQUENTLY RECOMMENDED THAT THE PATIENT RETURN THE DEVICE AND DISCONTINUE SERVICE. THE RETURN AND CANCELLATION WERE PROCESSED, AND THE SPOUSE WAS INFORMED ABOUT THE RETURN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497569 CALA KIQ EXTERNAL UPPER LIMB TREMOR STIMULATOR QBC CALA HEALTH INC TLA-3268, TLA-3270, TLA3269 2410161001, 2411181002 00851749007412

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention| O