BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HISTOSONICS EDISON

    MDR report key: 25137675 · Received May 11, 2026

    Report

    Report Number
    MW5187922
    Event Type
    Injury
    Date Received
    May 11, 2026
    Date of Event
    March 23, 2026
    Report Date
    May 4, 2026
    Manufacturer
    HISTOSONICS, INC.
    Product Code
    QGM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6). (B)(6) THERE BUT NEVER HEARD OF (B)(6). (B)(6) WHO ARE (B)(6) IF (B)(6). NO ONE (B)(6). (B)(6) AND WAS (B)(6). THERE WERE NO (B)(6). WHENEVER (B)(6), THEY (B)(6). ALL THE (B)(6) ESPECIALLY BY (B)(6). (B)(6) FORGOT (B)(6). THE (B)(6) THAT THE (B)(6) USES TO (B)(6) WHENEVER A (B)(6) NEVER WORKED AND (B)(6) UNDERMINING THE (B)(6). PT: 4580. DEVICE: 2017. REF: MW5187923.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462265 HISTOSONICS EDISON FOCUSED ULTRASOUND SYSTEM FOR NON-THERMAL, MECHANICAL TISSUE ABLATION QGM HISTOSONICS, INC. EDISON 3.2.1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown