BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTWAVETRT

    MDR report key: 18660861 · Received February 6, 2024

    Report

    Report Number
    MW5151136
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    November 27, 2023
    Report Date
    February 3, 2024
    Manufacturer
    SOFTWAVE TISSUE REGENERATON TECHNOLOGIES, LLC. DBA AS SOFTWAVE TRT
    Product Code
    ISA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SOFTWAVETRT: SIGNED UP FOR A CONSULTATION/SAMPLE FOR SOFTWAVETRT TREATMENT ON MY BACK/SHOULDER BLADE ARE AND WAS OFFERED A PACKAGE FOR MULTIPLE TREATMENTS. THE TECHNICIAN DID A LITTLE ON MY SHOULDER BLADE BUT FOCUSED ON MY SHOULDER AND LEFT TRAPEZIUS. MY 2ND TREATMENT ON (B)(6) 2023 RESULTED IN A VIBRATION IN MY EARS THAT WENT AWAY AFTER A DAY. MY 3RD TREATMENT LEFT ME WITH RINGING IN BOTH EARS, MORE ON THE LEFT. THE TECHNICIAN SAID THE RINGING COULD NOT BE CAUSED BY THE SOFTWAVE, BUT AFTER A 4TH TREATMENT, I HAD RINGING, PRESSURE, AND PAIN IN MY EARS. I STILL HAVE THE RINGING IN BOTH EARS AND INCREASED VOLUME AS OF (B)(6) 2024. I ALSO HAVE TIMES OF NOISE SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809598 SOFTWAVETRT MASSAGER, THERAPEUTIC, ELECTRIC ISA SOFTWAVE TISSUE REGENERATON TECHNOLOGIES, LLC. DBA AS SOFTWAVE TRT

    Patients

    Seq Age Sex Outcome Treatment
    1