MAUDE Adverse Event Report: SOLTA MEDICAL, INC THERMAGE CPT SYSTEM; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.

Model Number TTNS3.00E4-1200

Device Problem Degraded (1153)

Patient Problems Erythema (1840); Swelling/ Edema (4577)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

A user facility reported that during a thermage cpt treatment, the patient had moderate erythema and edema presenting as 3-5mm spots on their cheeks and that the treatment tip appeared to be damaged.The doctor applied 0.5% hydrocortisone cream immediately post-treatment to their cheeks.It is reported that the patient''s current status is back to their baseline and they have no scarring.The medical reviewer has deemed this event as not serious.The treatment tip was returned to solta for an evaluation and dielectric breakdown was observed.

Manufacturer Narrative

The treatment tip was returned and the evaluation was completed.During evaluation of the treatment tip, service found dielectric breakdown.The tip passed the flow test, thermistor test and leak test.The tip failed the visual inspection as dielectric breakdown was observed.No functional testing was performed due to the dielectric breakdown.According to thermage cpt system technical user¿s manual, swelling may occur and typically resolves within 5 days, but can persist up to several weeks.Application of cold compresses or gels immediately following the treatment may help to reduce the occurrence of this event.Erythema/blanching may occur in mild form and typically resolve within a few hours.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.Based on the available information, redness and swelling that occur during treatment were most likely caused by damage on the tip membrane.No corrective action is required.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: juli moore ; 3365 tree court ind blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 15433311
• MDR Text Key: 304523529
• Report Number: 3011423170-2022-00118
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TTNS3.00E4-1200
• Device Catalogue Number: TTNS3.00E4-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1