BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 10161088 · Received June 17, 2020

    Report

    Report Number
    9615058-2020-00011
    Event Type
    Injury
    Date Received
    June 17, 2020
    Report Date
    June 17, 2020
    Manufacturer
    INSIGHTEC LTD
    Product Code
    POH
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS POSTED ON THE COMPANY (B)(6) PAGE. THERE WERE NOT ENOUGH DETAILS TO LOCATE THE SITE, THE SPECIFIC TREATMENT OR THE TREATING PHYSICIAN. NOT ENOUGH DETAILS TO INVESTIGATE.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS POSTED ON INSIGHTEC (B)(6) PAGE. ACCORDING TO THE POST, THE PATIENT (COMPLAINANT'S IN-LAW) "SUFFERED A STROKE WITHIN A DAY AFTERWARDS". BASED ON THE AVAILABLE INFORMATION, THE COMPANY DOES NOT HAVE ENOUGH DETAILS TO LOCATE THE SITE OR THE TREATING PHYSICIAN. IN ADDITION, ACCORDING TO THE AVAILABLE INFORMATION, NO ABILITY TO DETERMINE WHAT IS THE RESULT OF THE REPORTED STROKE OR IF IT IS RELATED TO THE TREATMENT. THE COMPLAINANT RECEIVED A POST BACK THAT SHE SHOULD REACH HIS TREATING PHYSICIAN OR CONTACT INSIGHTEC FORMAL WEBSITE. NO FURTHER INFORMATION WAS RECEIVED REGARDING THIS CASE SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625197 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability