BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, BONE GROWTH, NON-INVASIVE

    MDR report key: 6940489 · Received October 11, 2017

    Report

    Report Number
    0002242816-2017-00045
    Event Type
    Injury
    Date Received
    October 11, 2017
    Report Date
    October 11, 2017
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    PMA / PMN Number
    PP850022
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FULL 510K(PMA) #: 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. 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 #: 0002242816-2017-00044.

    Description of Event or Problem · 1

    THE PATIENT STATED HE DEVELOPED WELTS WHILE USING THE ELECTRODES. THE PATIENT DESCRIBED HIS SKIN AS "RAW." HIS DOCTOR PRESCRIBED BETAMETHASONE DIPROPIONATE CREAM 5% FOR HIS SYMPTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722134 STIMULATOR, BONE GROWTH, NON-INVASIVE SOFT-TOUCH ELECTRODES, 72R LOF EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention