BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT TOUCH ELECTRODE, SOFT TOUCH ELECTRODE BODYMED SELF- ADHEARING ELECTRODE

    MDR report key: 15462221 · Received September 20, 2022

    Report

    Report Number
    MW5112160
    Event Type
    Injury
    Date Received
    September 20, 2022
    Date of Event
    August 16, 2022
    Report Date
    September 16, 2022
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT DEVELOPED ALLERGIC CONTACT DERMATITIS TO SOFT TOUCH ELECTRODES EBI CAT 5212-105, SOFT TOUCH ELECTRODES EBI CAT 6323-097. SHE WAS HAVING PRURITIC, ERYTHEMATOUS, RAISED, FIXED RASHES AFTER USE OF THESE PRODUCTS. SHE WAS SEEN IN OUR ALLERGY/IMMUNOLOGY CLINIC AND WE PATCH TESTED HER TO NACDG PANEL AS WELL AS OPEN PATCHES TO THESE ELECTRODES. SHE HAD LARGE POSITIVE TO THE ELECTRODES CONSISTENT WITH ALLERGIC CONTACT DERMATITIS. HER NACDG PANEL WAS NEGATIVE. WE ARE NOT CERTAIN WHAT INGREDIENT WITHIN THESE ELECTRODES TRIGGERED HER CONTACT ALLERGY. ATTEMPTS TO REACH THE MANUFACTURER WERE UNSUCCESSFUL. NACDG PANEL OF CONTACT ALLERGENS ALL NEGATIVE SOFT TOUCH ELECTRODES - POSITIVE (2+) BODYMED SELF-ADHERING ELECTRODE - POSITIVE (1+) STIMULATING ELECTRODES PROTENS (BLUE GEL) - NEGATIVE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567817 SOFT TOUCH ELECTRODE, SOFT TOUCH ELECTRODE BODYMED SELF- ADHEARING ELECTRODE STIMULATOR, BONE GROWTH, NON-INVASIVE LOF EBI, LLC.
    567818 SOFT TOUCH ELECTRODE, SOFT TOUCH ELECTRODE BODYMED SELF- ADHEARING ELECTRODE STIMULATOR, BONE GROWTH, NON-INVASIVE LOF EBI, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Other TRIAMCINOLONE