BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMIGEN

    MDR report key: 18165464 · Received November 17, 2023

    Report

    Report Number
    3006404071-2023-00001
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    November 15, 2021
    Report Date
    November 16, 2023
    Manufacturer
    SPINESMITH HOLDING, LLC
    Product Code
    GEI
    UDI-DI
    00817371020014
    PMA / PMN Number
    K130689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THERMIRF GENERATOR IS USED IN CONJUNCTION WITH THERMIRF INJECTABLE ELECTRODE AND GROUNDING PAD FOR THERMITIGHT PROCEDURE. CUSTOMER CASE REOPENED IN RESPONSE TO FDA AUDIT, INSPECTOR INDICATED THAT NO ADVERSE EVENT WAS REPORTED AND CASE REQUIRED RE-ASSESSMENT. QUALITY RE-OPENED THE CASE FOR RE-ASSESSEMENT OF MDR STATUS. RE-ASSESSMENT CONCLUDED THAT CASE IS REPORTABLE.

    Description of Event or Problem · 0

    PHYSICIAN'S OFFICE ACCT# (B)(4) REPORTED A BURN ON (B)(6) 2021 TO SALES REPRESENTATIVE. THERMITIGHT PROCEDURE WAS PERFORMED ON (B)(6) 2023 ON THE PATIENT'S NECK AND SUBMENTAL AREA AFTER SUBMENTAL LIPSUCTION. THE TREATMENT SET TEMPERATURE WAS 65C, AND DURING TREATMENT THE READINGS WERE BETWEEN 65-67C. THE SURGICAL TECHNICIAN MONITORING THE "EXTERNAL TEMP" READ A TEMPERATURE RANGE OF 35-40C. DURING TREATMENT THERE WAS NO INDICATION OF BURNS, SKIN WAS WARM AND PERFUSING APPROPRIATELY. TREATMENT TIME OF THE PROCEDURE WAS 20 MINUTES. AFTER THE TREATMENT WHILE CLEANING, IT WAS NOTICED THAT THE PATIENT'S SKIN WAS PINK AND PEELING ON THE LEFT SIDE OF THE PATIENT'S NECK BUT DID NOT EXHIBIT OPEN AREAS INDICATIVE OF COOL COMPRESS AND VASELINE. THE PATIENT WAS "WRAPPED" PER USUAL POST PROCEDURE. THE DAY FOLLOWING THE PROCEDURE, THE PATIENT RETURN WITH SIGNIFICANT BLISTERING ON RIGHT SIDE OF NECK AND OPEN AREAS ON LEFT SIDE OF THE NECK AND BURNS IN THE SUBMENTAL AREA. IMAGES OF THE PATIENT WAS PROVIDED, OFFICE PERSONNEL NOTED THAT THE PROTOCOL HAS BEEN FOLLOWED, AND THAT THERE WERE TWO PEOPLE MONITORING TEMPERATURE WITH NO INDICATION THAT THE SKIN WAS "TOO HOT" CITING CONCERNS ABOUT THE INFRARED CAMERA TEMPERATURE READINGS. IT WAS INDICATED THAT THE USER WAS NOT COMPLETELY KNOWLEDGEABLE ABOUT THE PROCESS WHERE IT APPLIES TO THE "HOTSPOT" MODE ON THE INFRARED CAMERA. THIS INDICATION LED TO THE CONCLUSION THAT USER ERROR MAY HAVE CAUSED THE EVENT. THE NURSE PRACTITIONER WHO PERFORMED THE PROCEDURE TREATED THE PATIENT ON (B)(6) 2021 FOR BURNS AND PROVIDED INSTRUCTIONS FOR HOME CARE. THE PATIENT DID NOT SHOW UP ON (B)(6) 2021. THE PATIENT WAS REFERRED TO THE (B)(6) CLINIC BY OFFICE STAFF ON (B)(6) 2021 AND SEEN BY THE (B)(6) CLINIC ON (B)(6) 2021 AS WELL AS (B)(6) 2021. PHYSICIAN RETURNED THEIR THERMIRF GENERATOR SN# (B)(6) AND FLIR CAMERA SN# (B)(6) FOR INSPECTION AND TESTING TO DETERMINE IF ANY EQUIPMENT FAILURE OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511537 THERMIGEN THERMI RF GENERATOR GEI SPINESMITH HOLDING, LLC G1 00817371020014

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention DISPERSIVE GROUNDING PAD #2130AC.| FLIR CAMERA SN#(B)(6).| RFE-10-D INJECTABLE RF ELECTRODE UNK LOT#.