BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODES, LT-4500

    MDR report key: 5974091 · Received September 23, 2016

    Report

    Report Number
    0002242816-2016-00027
    Event Type
    Injury
    Date Received
    September 23, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 7, 2016
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    PMA / PMN Number
    PP80022
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PMK/510 # P80022/S017. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVEN CAN OCCUR. THE PRODUCT WAS DISCARDED BY THE PATIENT; THEREFORE IT WILL NOT BE RETURNED FOR AN EVALUATION. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. 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 1 OF 3 FOR THE SAME EVENT. REPORTS 2 AND 3 ARE REPORTED ON MFR #0002242816-2016-00028 AND 0002242816-2016-00029.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT THE PATIENT EXPERIENCED A BURN FROM USING LT 4500 ELECTRODES AND 63B ELECTRODES WITH THE SPINALPAK. THE PATIENT WENT TO HIS DOCTOR FOR HIS SYMPTOMS. HIS DOCTOR PRESCRIBED HIM A CREAM. THE PATIENT ADVISED HE HAD TO MISS SOME WORK DAYS AS A RESULT OF THE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625559 ELECTRODES, LT-4500 ELECTRODES LOF EBI, LLC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention