BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINALPAK(R) STIMULATOR ELECTRODES

    MDR report key: 6402426 · Received March 14, 2017

    Report

    Report Number
    0002242816-2017-00008
    Event Type
    Injury
    Date Received
    March 14, 2017
    Report Date
    November 14, 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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/ 510(K) #: 850022/S017. IT WAS CONFIRMED THE ELECTRODE GELS DO NOT CONTAIN CORN. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE PRODUCT IS STILL 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. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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 THREE OF THREE FOR THE SAME EVENT. REPORT ONE AND TWO FOR THE SAME EVENT ARE REPORTED ON MFR #:0002242816-2017-00006 AND 0002242816-2017-00007.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE ADVISED THE PATIENT WAS HAVING AN ALLERGIC REACTION TO ALL OF THE ELECTRODES. THE PATIENT BROKE OUT IN A BLISTERING RASH. THE PATIENT ADVISED HER ALLERGIST GAVE HER AN ANTIBIOTIC CREAM FOR HER SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185806 SPINALPAK(R) STIMULATOR ELECTRODES SOFT-TOUCH ELECTRODES, 72R LOF EBI, LLC. N/A UNKKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention