BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIO 10 MOXA - SEDATELEC

    MDR report key: 4871931 · Received June 25, 2015

    Report

    Report Number
    8020802-2015-00001
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    March 13, 2015
    Report Date
    June 24, 2015
    Manufacturer
    SEDATELEC
    Product Code
    MQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PREMIO 10 - MOXA IS INDICATED FOR TEMPORARY RELIEF OF MINOR MUSCLE AND JOINT PAIN, ARTHRITIS AND MUSCLE SPASM, RELIEVING STIFFNESS, PROMOTING RELAXATION OF MUSCLE TISSUE, AND TO TEMPORARILY INCREASE LOCAL BLOOD CIRCULATION WHERE HEAT IS INDICATED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A PT RECEIVED MOXIBUSTION TREATMENT WITH THE DEVICE PREMIO 10 MOXA WHICH WAS CARRIED OUT BY AN ACUPUNCTURIST. IT HAS HEATED NEEDLES IN THE PATIENT'S KNEES. FOLLOWING TREATMENT, BURNS TO THE LEFT AND RIGHT KNEES WERE OBSERVED. ON (B)(6) 2015, THE PT MET HIS FAMILY DOCTOR AND THIS ONE, AT THE STATE OF THE LEGS OF THE PT, REQUESTED A PLASTIC SURGERY CONSULTATION. ON (B)(6) 2015, THE PT MET A SPECIALIST AND IT CONFIRMED SECOND DEGREE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412063 PREMIO 10 MOXA - SEDATELEC PREMIO 10 MQX SEDATELEC 2177

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability LAMP INTENDED TO PROVIDE TOPICAL HEATING.| THE PREMIO 10 - MOXA IS A NON-INVASIVE INFRARED,