BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT-TOUCH ELECTRODES, 63B

    MDR report key: 6242778 · Received January 11, 2017

    Report

    Report Number
    0002242816-2017-00002
    Event Type
    Injury
    Date Received
    January 11, 2017
    Report Date
    December 19, 2016
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    PMA / PMN Number
    PP850022
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): P850022/S017. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE PRODUCT IS STILL BEING USED BY THE PATIENT AND THEREFORE WILL NOT BE RETURNED FOR AN EVALUATION. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. THE PATIENT ADVISED SHE HAS VERY SENSITIVE SKIN AND GOES TO SEE HER DERMATOLOGIST EVERY THREE MONTHS. THE PATIENT ADVISES SHE BREAKS OUT FROM WEARING BAND AIDS AS WELL. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THIS IS REPORT TWO OF TWO FOR THE SAME EVENT. REPORT ONE OF TWO IS REPORTED ON MFR #0002242816-2017-00001.

    Description of Event or Problem · 1

    THE PATIENT STATED SHE IS EXPERIENCING SKIN IRRITATION ISSUES WITH THE ELECTRODES. THE PATIENT ADVISED SHE IS TAKING A BREAK FROM USING THEM FOR A COUPLE OF WEEKS UNTIL HER SKIN HEALED COMPLETELY PER THE INSTRUCTIONS FROM HER DOCTOR. THE PATIENT ADVISED HER DERMATOLOGIST PRESCRIBED HER SOME STEROID OINTMENT TO HELP WITH RELIEF FROM THE SKIN IRRITATION. THE PATIENT STATES SHE CANNOT TREAT WITH THE ELECTRODES FOR MORE THAN FIVE MINUTES WITHOUT GETTING RED AND ITCHY. THE PATIENT ADVISED SHE CHANGES THE ELECTRODES EVERY NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25701 SOFT-TOUCH ELECTRODES, 63B ELECTRODES LOF EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention