MAUDE Adverse Event Report: SPINESMITH HOLDINGS,LLC THERMIGEN; THERMIRF+ GENERATOR

Catalog Number	THERMIRF+
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: THERMIGEN
• Common Device Name: THERMIRF+ GENERATOR
• Manufacturer (Section D): SPINESMITH HOLDINGS,LLC; 4719 south congress ave; austin TX 78745
• Manufacturer Contact: candace mckinnis ; 4719 south congress ave; austin, TX 78745 ; 5126376745
• MDR Report Key: 18707983
• Report Number: 3006404071-2024-00003
• Device Sequence Number: 7126894
• Product Code: DWG
• UDI-Device Identifier: 00817771029044
• UDI-Public: 00817771029044
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: THERMIRF+
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female