BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 14451231 · Received May 20, 2022

    Report

    Report Number
    9615058-2022-00014
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    April 22, 2022
    Report Date
    May 18, 2022
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    POH
    UDI-DI
    07290015461021
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INCLUDED KNOWN SIDE EFFECTS. NO NEW RISKS WERE RECOGNIZED.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED PATIENT HAD HEMIPARESIS, TWO DAYS AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346029 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000 07290015461021

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability