BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMIRF

    MDR report key: 18167245 · Received November 19, 2023

    Report

    Report Number
    3006404071-2023-00005
    Event Type
    Injury
    Date Received
    November 19, 2023
    Date of Event
    March 12, 2020
    Report Date
    November 19, 2023
    Manufacturer
    SPINESMITH HOLDINGS,LLC
    Product Code
    DWG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS NOT RETURNED FOR EVALUATION. INVESTIGATION OF CALL RESULTED IN PHYSICIAN REPORTING THAT THE INITIAL CALL WAS NOT AN ADVERSE EVENT BUT AN INQUIRY ON THE USER OF RETINOL CREAM AND THE THERMISMOOTH PROCEDURE.

    Description of Event or Problem · 0

    ON 03/12/2020, ACCOUNT CONTACTED SPINESMITH REQUESTING INFORMATION ON THE USE OF RETINOL CREAM PRIOR TO THERMI TREATMENTS. CALLER REPORTED THAT A THERMISMOOTH PROCEDURE WAS COMPLETED ON A PATIENT THAT RESULTED IN A FEW BURNS ON THE PATIENTS FACE. CALLER REPORTED THE PATIENT HAD USED RETINOL CREAM PRIOR TO THE PROCEDURE. THE ACCOUNT IS REQUESTING INFORMATION ON WHETHER OR NOT RETINOL CREAM PRIOR TO THE PROCEDURE WOULD CAUSE BURNS. NO ADDITIONAL INFORMATION WAS OBTAINED, ALTHOUGH ATTEMPTS TO COLLECT MORE INFORMATION WAS MADE VIA EMAIL ON 03/12/2020 AND 03/16/2020. ON 03/19/2023, PHYSICIAN NOTIFIED SPINESMITH THAT THE INITIAL CALL DETAILS WERE NOT ACCURATE, NO ADVERSE EVENT OCCURRED AND INSTEAD SHE HAD A QUESTION: WOULD THERE BE ANY EFFECTS OF USING RETINAL; PRODUCTS BEFORE OR AFTER A THERMISMOOTH PROCEDURE?. QUESTION WAS SENT TO THE THEN CLINICAL TEAM. NO ADDITIONAL COMPLAINT DETAILS WERE RECORDED AND CASE WAS CLOSED ON 06/14/2021. DURING 2023 FDA AUDIT, INSPECTOR INDICATED THE COMPLAINED REQUIRED RE-ASSESSMENT. COMPLAINT WAS RE-OPENED ON 08/04/2023. A FOLLOW UP CALL WAS MADE ON 08/08/2023, DURING THE CALL IT WAS REPORTED THAT THE PHYSICIAN THAT HAD MADE THE INITIAL CALL WAS NO LONGER WITH THE PRACTICE AS SHE HAD RETIRED. THEY ALSO REPORTED THAT THEY HAD DISCONTINUED THE THERMISMOOTH PROCEDURE DURING COVID AND HAVE LIMITED STAFF AVAILABILITY TO PERFORM THE PROCEDURE. AS OF 08/08/2023, PRACTICE DOES NOT HAVE ANY ISSUES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925378 THERMIRF RF GENERATOR DWG SPINESMITH HOLDINGS,LLC THERMIRF

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other #2130AC GROUNDING PAD.| RFE-10-D-G2 ELECTRODE.