BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXOGEN ULTRASOUND BONE HEALING SYSTEM

    MDR report key: 12600500 · Received October 8, 2021

    Report

    Report Number
    3010203571-2021-00012
    Event Type
    Death
    Date Received
    October 8, 2021
    Date of Event
    June 23, 2020
    Report Date
    September 14, 2021
    Manufacturer
    BIOVENTUS LLC
    Product Code
    LOF
    UDI-DI
    M937710344001G
    PMA / PMN Number
    P900009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE CONCLUSIONS CAN BE MADE IN REGARDS TO THE REPORTED EVENT. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. A FOLLOW UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT PRESCRIBED THE EXOGEN SYSTEM FOLLOWING FOOT SURGERY IN (B)(6) 2020, CONTRACTED AN INFECTION. SUBSEQUENTLY, THE PATIENT WAS REPORTED TO HAVE ELEVATED BLOOD PRESSURE AND PASSED AWAY THE SAME DAY. THE CAUSE OF PATIENTS' DEATH IS UNKNOWN. ADDITIONALLY IT IS UNKNOWN WHAT TYPE OF BACTERIA CAUSED THE REPORTED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498357 EXOGEN ULTRASOUND BONE HEALING SYSTEM EXOGEN LOF BIOVENTUS LLC 71034400 20CM15740 M937710344001G

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death| O