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

Model Number	THERMIRF+
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burning Sensation (2146); Discomfort (2330)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: THERMI
• Common Device Name: THERMIRF+ GENERATOR
• Manufacturer (Section D): SPINESMITH HOLDINGS,LLC; 4719 south congress ave; austin TX 78745
• Manufacturer Contact: chriselda martinez ; 4719 south congress ave; austin, TX 78745 ; 5126376745
• MDR Report Key: 18627617
• Report Number: 3006404071-2024-00001
• Device Sequence Number: 7889382
• Product Code: DWG
• UDI-Device Identifier: 00817771029044
• UDI-Public: 00817771029044
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173582
• 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: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 02/01/2024

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
• Device Model Number: THERMIRF+
• Device Catalogue Number: THERMIRF+
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DISPOSABLE DISPERSIVE GROUNDING PAD #2130AC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female