BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 2100

    MDR report key: 15379069 · Received September 8, 2022

    Report

    Report Number
    9615085-2022-00021
    Event Type
    Injury
    Date Received
    September 8, 2022
    Date of Event
    June 29, 2022
    Report Date
    September 7, 2022
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    NRZ
    PMA / PMN Number
    P040003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TREATMENT PARAMETERS WERE IN LINE WITH THE TYPICAL RANGE. THIS COMPLAINT INCLUDED KNOWN SIDE EFFECTS. NO NEW RISKS WERE IDENTIFIED. NO DEVICE MALFUNCTION WAS DETECTED.

    Description of Event or Problem · 0

    PATIENT HAD ABDOMINAL 2ND DEGREE SKIN BURN, WITH BLISTERS IN THE BURN AREA, WITH DIMENSIONS OF APPROXIMATELY 5 X 4 CM, IMMEDIATELY AFTER UF TREATMENT. PATIENT RECEIVED STANDARD DISINFECTION AND ANTIBACTERIAL DRUGS TREATMENT. HOWEVER, PATIENT DECIDED TO STOP MEDICATIONS INTAKE AND UNDERGO SURGERY. PATIENT UNDERWENT SURGERY ON (B)(6) 2022, AT ANOTHER HOSPITAL, AND IS FEELING WELL, AS OF (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237047 EXABLATE 2100 MR GUIDED FOCUSED ULTRASOUND SYSTEM NRZ INSIGHTEC LTD. 2100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability| R