BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINALPAK SOFT-TOUCH ELECTRODES, 72R

    MDR report key: 6120903 · Received November 22, 2016

    Report

    Report Number
    0002242816-2016-00039
    Event Type
    Injury
    Date Received
    November 22, 2016
    Report Date
    November 10, 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

    P850022/S017. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE PRODUCT WAS DISCARDED 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 REPORTED GOING TO THE URGENT CARE THE WEEKEND PRIOR TO (B)(6) 2016 WHERE SHE WAS TOLD SHE WAS HAVING AN ALLERGIC REACTION TO THE 72R ELECTRODES. 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED RECEIVING THE SPINALPAK ON (B)(6) 2016. SOON AFTER SHE EXPERIENCED ITCHING AND PAINFUL BLISTERS ON BOTH SIDES OF THE SPINAL COLUMN UNDER THE ELECTRODES ON HER LOWER BACK. THE PATIENT REPORTED GOING TO THE URGENT CARE THE WEEKEND PRIOR TO (B)(6) 2016 WHERE SHE WAS TOLD SHE WAS HAVING AN ALLERGIC REACTION TO THE 72R ELECTRODES. THE PATIENT ADVISED SHE WAS ALSO USING COVER PATCHES. THE PATIENT ADVISED SHE CHANGED HER ELECTRODES EVERY THREE DAYS OR MORE WHEN THE COVER PATCHES NO LONGER HELD THE ELECTRODES IN PLACE. THE PATIENT ADVISED SHE'D MOVE THE ELECTRODES A LITTLE BIT. THE PATIENT ADVISED SHE RECEIVED TRIAMCINOLONE, PREDNISONE, AND HYDROXYZINE FROM THE URGENT CARE CENTER. THE PATIENT ADVISED SHE WAS TOLD TO DISCONTINUE USE BY HER SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773494 SPINALPAK SOFT-TOUCH ELECTRODES, 72R ELECTRODES LOF EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention