BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET NON INVASIVE BONE GROWTH STIMULATOR

    MDR report key: 6751690 · Received July 28, 2017

    Report

    Report Number
    0002242816-2017-00038
    Event Type
    Injury
    Date Received
    July 28, 2017
    Report Date
    July 28, 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
    HI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FULL PMA NUMBER: P850022/S017. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORDS ARE UNABLE TO BE 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, REFERENCE REPORT 0002242816-2017-00037.

    Description of Event or Problem · 1

    THE PATIENT REPORTED DEVELOPING AN ITCHY RED RASH WHEN SHE USED THE LT4500 AND 63B ELECTRODES. SHE SPOKE WITH HER PHYSICIAN WHO PRESCRIBED BETAMETHASONE DIPROPIONATE. THE PATIENT ALSO ADVISED SHE HAS BEEN USING MEDICAL TAPE INSTEAD OF THE COVER PATCHES AS SHE NEEDED SOMETHING HYPOALLERGENIC. SHE STATES SHE DOES NOT HAVE SENSITIVE SKIN. SHE STATED THE 72R ELECTRODES WORK THE BEST FOR HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531094 BIOMET NON INVASIVE BONE GROWTH STIMULATOR SOFT-TOUCH ELECTRODES, 63B LOF EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other