BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 2100

    MDR report key: 16416337 · Received February 22, 2023

    Report

    Report Number
    9615058-2023-00005
    Event Type
    Injury
    Date Received
    February 22, 2023
    Date of Event
    January 23, 2023
    Report Date
    February 22, 2023
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    NRZ
    PMA / PMN Number
    P040003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INCLUDES KNOWN SIDE EFFECT FOR UF TREATMENT. NO NEW RISKS WERE IDENTIFIED. NO DEVICE MALFUNCTION WAS DETECTED. TREATMENT PARAMETERS WERE IN LINE WITH THE TYPICAL RANGE.

    Description of Event or Problem · 0

    SKIN BURN FOLLOWING UTERINE FIBROIDS (UF) TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612289 EXABLATE 2100 MR GUIDED FOCUSED ULTRASOUND SYSTEM NRZ INSIGHTEC LTD. 2100

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability