BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE MRGFUS

    MDR report key: 6829296 · Received August 29, 2017

    Report

    Report Number
    9615058-2016-00002
    Event Type
    Injury
    Date Received
    August 29, 2017
    Date of Event
    February 5, 2016
    Report Date
    August 29, 2017
    Manufacturer
    INSIGHTEC, LTD.
    Product Code
    NRZ
    UDI-DI
    07290015461016
    PMA / PMN Number
    P040003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN EVALUATED AND DETERMINED IT WORKS PER ITS SPECIFICATIONS AND LABELED INDICATIONS. TREATMENT RESULTING IN ALLEGED INJURY WAS OFF-LABEL USE NOT IN ACCORDANCE WITH APPROVED INDICATIONS. (B)(4). NOTE: INITIAL REPORT SUBMITTED TO FDA IN 9615058-2016-00002 ON 03-02-2016 BUT NOT VISIBLE IN MAUDE. FOLLOW-UP REPORT BEING SUBMITTED FOR TRACEABILITY/ DOCUMENTATION PURPOSES ONLY. THERE IS NO CHANGE FROM THE INITIAL REPORT.

    Description of Event or Problem · 1

    TREATING PHYSICIAN REPORTED TO INSIGHTEC AN EVENT RELATED TO OFF-LABEL USE OF EXABLATE 2100 (P040003/S016 UTERINE FIBROIDS INDICATION) ON (B)(6) YEAR OLD MALE. PER THEIR REPORT, THE POST-TREATMENT EXAMINATION OF THE SKIN SHOWED A 5CM THIRD DEGREE SKIN BURN WITH BLISTERING. THE CENTER OF THIS BURN WAS WHITE SURROUNDED WITH A HYPEREMIC AREA. THE PATIENT WAS PRESCRIBED FOR ANTIBIOTICS TO MINIMIZE THE RISK OF INFECTION AND IS NOW UNDER THE CARE OF PLASTIC SURGERY AND DERMATOLOGY FOR WOUND CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608450 EXABLATE MRGFUS MR GUIDED FOCUSED ULTRASOUND NRZ INSIGHTEC, LTD. 2100 07290015461016

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization