BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMI

    MDR report key: 18627617 · Received February 1, 2024

    Report

    Report Number
    3006404071-2024-00001
    Event Type
    Injury
    Date Received
    February 1, 2024
    Date of Event
    November 8, 2023
    Report Date
    February 1, 2024
    Manufacturer
    SPINESMITH HOLDINGS,LLC
    Product Code
    DWG
    UDI-DI
    00817771029044
    PMA / PMN Number
    K173582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON FOLLOW UP, OFFICE STAFFF REPORTED THAT THEY ARE TREATING THE PATIENTS SCARS BUT THE PATIENT IS OK. THEY ALSO REPORTED THAT AFTER RECEIVING THEIR THERMIRF+ BACK THE CONTINUE TO NOT HAVE ISSUES.

    Description of Event or Problem · 0

    PATIENT NOTICED A BURN ON RIGHT THIGH WHERE GROUNDING PAD WAS PLACED DURING HER THERMIVA TREATMENT WHEN SHE ARRIVED HOME. OFFICE STAFF REPORTED THAT DURING THE TREATMENT PATIENT MENTIONED THAT THERE WAS A SENSATION OF HEAT WHERE THE GROUNDING PAD WAS PLACED, SO THE NURSE RE-APPLIED THE GROUNDING AND THE PATIENT REPORTED THAT THEY FELT FINE SO THE TREATMENT PROCEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347805 THERMI THERMIRF+ GENERATOR DWG SPINESMITH HOLDINGS,LLC THERMIRF+ 00817771029044

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention DISPOSABLE DISPERSIVE GROUNDING PAD #2130AC