BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYMEDICA ORTHOPEDICS E-VIVE

    MDR report key: 9835882 · Received March 16, 2020

    Report

    Report Number
    3011466827-2020-00001
    Event Type
    Injury
    Date Received
    March 16, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 4, 2020
    Manufacturer
    CYMEDICA ORTHOPEDICS, INC.
    Product Code
    GZJ
    UDI-DI
    00854691008414
    PMA / PMN Number
    K163067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020, A CLINICAL SUBJECT REPORTED AN ELECTRODE BURN TO THE SITE WHICH WAS DOCUMENTED AS AN ADVERSE EVENT. UPON FURTHER DISCUSSIONS WITH THE CRC ON (B)(6) 2020, IT WAS DISCOVERED THE SUBJECT WAS APPLYING AN EXCESSIVE AMOUNT OF ELECTRODE GEL WHICH WOULD CAUSE ELECTRODE DAMAGE. THE CRC POTENTIALLY HAD INSTRUCTED THE SUBJECT TO APPLY SKIN LOTION SINCE SHE HAS INSTRUCTED OTHER SUBJECTS TO DO THE SAME. THE SPONSOR DISCUSSED WITH THE CRC THAT APPLYING LOTION BEFORE A TREATMENT COULD GENERATE ADDITIONAL HEAT AND CAUSE SKIN IRRITATION AND/OR BURN. THE CRC WAS ASKED TO CONTACT THE SUBJECT AND HAVE HER STOP APPLYING SKIN LOTION AND AN EXCESSIVE AMOUNT OF ELECTRODE GEL. THE SPONSOR ALSO INSTRUCTED THE CRC TO COMMUNICATE TO THE SUBJECT, AT ANY SIGN OF ELECTRODE DAMAGE THE ELECTRODES MUST BE REPLACED. THE SUBJECT IS CURRENTLY ENROLLED IN THE CLINICAL TRIAL AND WAS INSTRUCTED BY THE PRINCIPAL INVESTIGATOR TO STOP USING THE DEVICE FOR TWO DAYS. AT THE CONCLUSION OF THE TWO DAYS, THE SUBJECT CAN RESUME USING THE DEVICE AND REMAIN IN THE STUDY.

    Description of Event or Problem · 1

    THE PATIENT/SUBJECT IS CURRENTLY ENROLLED IN (B)(6) CLINICAL STUDY ((B)(6)). ON (B)(6) 2020, THE SUBJECT NOTIFIED THE SITE THAT SHE HAD MARKS CONSISTENT WITH A BURN IN THE LOCATION OF THE DEVICE ELECTRODES. TREATMENT WAS TEMPORARILY STOPPED FOR 2 DAYS THEN RESUMED ON (B)(6) 2020 UNDER THE CARE OF THE PRINCIPAL INVESTIGATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301493 CYMEDICA ORTHOPEDICS E-VIVE E-VIVE¿ NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) SYSTEM GZJ CYMEDICA ORTHOPEDICS, INC. CY-1000-216 1939-007205 00854691008414

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other