BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCELSTIM

    MDR report key: 17059858 · Received June 5, 2023

    Report

    Report Number
    2183449-2023-00001
    Event Type
    Injury
    Date Received
    June 5, 2023
    Report Date
    March 28, 2024
    Manufacturer
    ORTHOFIX
    Product Code
    LOF
    UDI-DI
    08050040997213
    PMA / PMN Number
    P210035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INCIDENT IS RELATED TO A SKIN IRRITATION PROBLEM. KONIX GEL K101952 IS A COMPONENT OF THE DEVICE. THERE WERE NO DYSFUNCTION, DEFICIENCIES/DETERIORATIONS FOUND WITH THE DEVICE. NO DEVICE MALFUNCTION HAS OCCURRED. THE REVIEW HAS DETERMINED THAT THE RISK ASSESSMENT IS STILL ADEQUATE.

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE RETURNED DEVICE WAS COMPLETED ON 08 MAY 2023. FIVE THERAPY SESSIONS WERE CONDUCTED, WITH THE LAST SESSION OCCURRING ON (B)(6) 2023, LASTING 10 MINUTES. DURING THE TREATMENT, DEVICE TEMPERATURE WAS CONTINUOUSLY MONITORED AND NEVER EXCEEDED 25°C. FOLLOWING THE TREATMENT, A BURN-IN TEST WAS CONDUCTED, WHICH REVEALED NO ERRORS. ADDITIONALLY, A FORCE BALANCE ASSESSMENT WAS PERFORMED TO DETERMINE ULTRASOUND INTENSITY VALUE, AND NO DEVIATIONS WERE DETECTED.

    Description of Event or Problem · 0

    INFORMATION PROVIDED STATES THAT PATIENT WAS PRESCRIBED ACCELSTIM DEVICE (B)(6) 2022. PT SAID SHE ONLY USED IT 3-4 TIMES. AFTER LAST TREATMENT RED BURNS APPEARED ABOUT THE SIZE OF THE DEVICE ON HER FOOT, 2-3 BURNS ON THE BACK BOTTOM OF HER FOOT WHERE THE DEVICE WAS AND ON THE TOP OF THE FOOT. SHE STOPPED USING THE DEVICE. PATIENT SAID THE BURNS HAVE SINCE HEALED . PT STATED SHE TRIED ALTERNATIVE MINERAL OIL AND GLYCERIN WITH THE SAME RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29304 ACCELSTIM BONE GROWTH STIMULATOR LOF ORTHOFIX 4300 08050040997213

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other