BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOVENTUS EXOGEN 4000J MOU ASSEMBLY

    MDR report key: 3775761 · Received April 25, 2014

    Report

    Report Number
    3010203571-2014-00001
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BIOVENTUS LLC
    Product Code
    LOF
    PMA / PMN Number
    P900009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE TREATING PHYSICIAN, THIS EVENT IS SERIOUS AND RELATED TO THE USE OF EXOGEN. A MEDICAL REVIEW WAS PERFORMED BY BOTH (B)(4) AND BIOVENTUS. NONE AGREES THAT THIS INCIDENT IS RELATED TO THE DEVICE. SKIN ULCERS MIGHT OCCUR DUE TO COMPONENTS OF THE CAST OR TAPE SUCH AS TRAPPED HUMIDITY UNDER THE TAPE OR CAST. THE EXOGEN ULTRASOUND DEVICE SIGNAL IS TOO WEAK TO CAUSE ANY SKIN OR TISSUE DAMAGE. THE PACKAGE INSERT OF THIS DEVICE STATES THAT THE UNIT SHOULD BE USED UNDER OBSERVATION DURING TREATMENT FOR OPERATIVE WOUNDS AND EXTERNAL WOUNDS. IF SKIN TROUBLE IS RECOGNIZED THEN THE PT MUST STOP USING THE DEVICE.

    Description of Event or Problem · 1

    AVERSE EVENT: CUTANEOUS ULCER. PER (B)(4), THE PRESCRIBING PHYSICIAN RECOGNIZED A CUTANEOUS ULCER WHEN HE REMOVED THE MEDICAL TAPE FROM THE PATIENT'S AFFECTED AREA (LEFT HUMERUS). THE PT WAS TREATING HER LEFT HUMERUS WITH EXOGEN DEVICE. NO MALFUNCTION OF THE DEVICE WAS REPORTED AS TREATMENT IS STILL CONTINUING WITH NO TROUBLE. ADVERSE EVENT: CUTANEOUS ULCER. PER (B)(4), THE PRESCRIBING PHYSICIAN RECOGNIZED A CUTANEOUS ULCER WHEN HE REMOVED THAT MEDICAL TAPE FROM THE PATIENT'S AFFECTED AREA (LEFT HUMERUS). THE PT WAS TREATING HER LEFT HUMERUS WITH EXOGEN DEVICE. THE DOCTOR RECOGNIZED THE WOUND HEALING ON (B)(6) 2014. NO MALFUNCTION OF THE DEVICE WAS REPORTED AS TREATMENT IS STILL CONTINUING WITH NO TROUBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252335 BIOVENTUS EXOGEN 4000J MOU ASSEMBLY BONE GROWTH STIMULATOR LOF BIOVENTUS LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other