BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET NON INVASIVE BONE GROWTH STIMULATOR SYSTEM

    MDR report key: 6740961 · Received July 25, 2017

    Report

    Report Number
    0002242816-2017-00033
    Event Type
    Injury
    Date Received
    July 25, 2017
    Report Date
    July 25, 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
    FL, 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. 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; REFERENCE REPORTS 0002242816-2017-00031 AND 0002242816-2017-00032.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE DEVELOPED A RASH. THE RASH DEVELOPED BLISTERS, HER SKIN BECAME RAW AND BLED AND THE RASH HAS SPREAD ALL OVER HER BODY. SHE SAW A DERMATOLOGIST ON (B)(6) 2017 WHO PRESCRIBED PREDNISONE TO TAKE ORALLY AND TRIAMCINOLONE CREAM. SHE ALSO STATED SHE DID NOT HAVE AN ISSUE USING THE LT 4500 ELECTRODES IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520716 BIOMET NON INVASIVE BONE GROWTH STIMULATOR SYSTEM ELECTRODE COVER PATCHES LOF EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention