BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMIGEN

    MDR report key: 18707983 · Received February 14, 2024

    Report

    Report Number
    3006404071-2024-00003
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    January 16, 2024
    Report Date
    February 14, 2024
    Manufacturer
    SPINESMITH HOLDINGS,LLC
    Product Code
    DWG
    UDI-DI
    00817771029044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESITGATION PLAN INCLUDES GETTING THE THERMIRF+ GENERATOR (SN# (B)(6)) INTO OUR FACILITIES TO INVESTIGATE THE UNIT. THE CUSTOMER HAS REQUESTED A LOANER GENERATOR IN THE MEAN WHILE TO PREVENT USE OF THE GENERATOR IN QUESTION. THE LOANER UNIT HAS MADE ITS WAY TO THE CUSTOMERS LOCATION. AS OF (B)(6) 2024, THE UNIT HAS NOT BEEN RECEIVED IN HOUSE. THERE HAS BEEN ATTEMPTS TO REACH OUT TO CUSTOMER TO GET THE STATUS OF THEIR THERMIRF+ GENERATOR. THE VP OF SALES IS WORKING ON GETTING A STATUS UPDATE OF THE THERMIRF+ GENERATOR LOCATION TO ENSURE IT GETS TO US FOR EVALUATION.

    Description of Event or Problem · 0

    ON 16JAN2024, CUSTOMER SUPPORT WAS NOTIFIED BY A SALES REPRESENTATIVE OF AN ADVERSE EVENT. CHETCO MEDICAL (ACCT #: (B)(4)) REPORTED A PATIENT THEY PERFORMED A THERMIVA TREATMENT HAD BURNS INSIDE HER VAGINA. THE THERMIVA TREATMENT WAS PERFORMED IN (B)(6) 2023. THE PATIENT REPORTED SHE FELT DISCOMFORT AFTER THE TREATMENT AND VISITED HER OBGYN IN (B)(6) 2023. THE PATIENT'S OBGYN INFORMED HER SHE HAD BURNS INSIDE HER VAGINA. THE CUSTOMER MENTIONED THEY WERE PERFORMING AGGRESSIVE TREATMENT DUE TO THE PATIENT'S URINARY INCONTINENCE. THE PATIENT ONLY HAD ONE THERMIVA TREATMENT IN (B)(6) WHEN IN (B)(6) HER OBGYN NOTIFIED HER OF THE BURN. THE CUSTOMER REPORTED IN (B)(6) THEY ARE PERFORMING PRP TREATMENTS FOR THE BURN ON THE PATIENT. THE CUSTOMER HAS NOT REPORTED ANY OTHER ISSUES WITH THE THERMIRF+ GENERATOR (SN #: (B)(6)). THE UNIT WAS REQUESTED FOR EVALUATION TO ENSURE IT IS FUNCTIONING AS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787485 THERMIGEN THERMIRF+ GENERATOR DWG SPINESMITH HOLDINGS,LLC 00817771029044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention