BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALA KIQ

    MDR report key: 24758785 · Received April 1, 2026

    Report

    Report Number
    3011628389-2026-00001
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 3, 2026
    Report Date
    April 1, 2026
    Manufacturer
    CALA HEALTH INC
    Product Code
    QBC
    UDI-DI
    00851749007412
    PMA / PMN Number
    K243848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DIAGNOSTIC STATUS: WHILE THE PATIENT REPORTED AN EPISODE OF ATRIAL FIBRILLATION (AFIB), CALA HAS NOT YET RECEIVED FORMAL DIAGNOSTIC CONFIRMATION FROM THE TREATING CARDIOLOGIST. PENDING DATA: THE RESULTS OF THE 14-DAY CARDIAC MONITOR AND THE FULL CARDIAC WORKUP RESULTS AND ADDITIONAL INFORMATION ARE CURRENTLY PENDING. CLINICAL INVESTIGATION DELAY: CALA HEALTH SENT THE MEDICAL COMPLAINT FOR REVIEW BY A LICENSED NEUROLOGIST, WHO REQUESTED ADDITIONAL MEDICAL HISTORY INFORMATION FROM THE PATIENT TO COMPLETE THE EVALUATION. HOWEVER, THE COMPLETION OF THIS EVALUATION HAS BEEN DELAYED AS THE PATIENT WAS INITIALLY HESITANT TO RELEASE MEDICAL RECORDS PENDING A REFUND REQUEST. CURRENTLY, THE REFUND REQUEST HAS BEEN RESOLVED AND FOLLOW-UP EFFORTS ARE NOW ONGOING. DEVICE INVESTIGATION: THE RETURNED DEVICE WAS TESTED AND FOUND TO BE FULLY FUNCTIONAL. A REVIEW OF THE DEVICE LOGS SHOWED NO EVIDENCE OF MALFUNCTION OR TECHNICAL ISSUES. RISK ANALYSIS CONTEXT: CALA HAS RECEIVED A TOTAL OF TWO MEDICAL DEVICE REPORTS AND THE CURRENT REPORT CONCERNING ATRIAL FIBRILLATION (AFIB) REQUIRING MEDICAL INTERVENTION OUT OF APPROXIMATELY (B)(4) SHIPPED CALA KIQ UNITS. THIS CORRESPONDS TO AN OBSERVED FREQUENCY OF 0.014%, OR APPROXIMATELY 1 IN (B)(4) UNITS, WHICH REMAINS CONSISTENT WITH THE "REMOTE" PROBABILITY CATEGORY (LEVEL 2: LESS THAN 1 IN 1,000, BUT MORE THAN 1 IN 10,000 FAILURES) DEFINED IN THE DEVICE HAZARD ANALYSIS (RSK-11014). THE OBSERVED SEVERITY AND FREQUENCY OF THIS EVENT ARE CONSISTENT WITH THE PREDEFINED RISK SCENARIOS AND EXPECTATIONS DESCRIBED IN THE DEVICE'S RISK MANAGEMENT DOCUMENTATION (RISK IDS 5.1.44 AND 5.1.54). CONCLUSION: CALA CONCLUDES THAT THE FREQUENCY AND SEVERITY OF THIS EVENT ARE CONSISTENT WITH EXPECTATIONS DESCRIBED IN THE DEVICE'S RISK MANAGEMENT DOCUMENTATION. NO NEW TRENDS OR UNEXPECTED PATTERNS HAVE BEEN IDENTIFIED TO DATE.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT APPROXIMATELY 30 MINUTES INTO A THERAPY SESSION, HE WENT INTO ATRIAL FIBRILLATION (AFIB). HE BEGAN TO FEEL CHEST DISCOMFORT FOLLOWED BY DIZZINESS AND DIFFICULTY WALKING, WHICH LED HIM TO DISCONTINUE THE SESSION. THE PATIENT STATED HE OBSERVED A RESTING HEART RATE OF 125 BPM AND "VERY HIGH" BLOOD PRESSURE.THE PATIENT CONSULTED A CARDIOLOGIST THE NEXT DAY, AND WAS PRESCRIBED A 14-DAY CARDIAC MONITOR FOR A SUSPECTED EPISODE OF ATRIAL FIBRILLATION (AFIB). CALA IS CURRENTLY IN COMMUNICATION WITH THE PATIENT TO OBTAIN THE NECESSARY SUPPLEMENTARY INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818474 CALA KIQ EXTERNAL UPPER LIMB TREMOR STIMULATOR QBC CALA HEALTH INC SW100, BW100, CW100S/M/L 2512101001, 2512031001 00851749007412

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male Required Intervention| O