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

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Abrasion (1689); Pain (1994)

Event Date 01/05/2019

Event Type  Injury  

Manufacturer Narrative

Investigation results are pending.Though requests for patient status updates have been made, to date no additional information has been received.

Event Description

A patient in (b)(6) reported that she experienced pain, bleeding, and scratches of the left face, forehead, and neck after receiving thermage treatment on (b)(6) 2019.There were no problems with the right face.It is unknown if the tip was inspected prior to use, or during treatment.However, during the procedure, the patient reports that the doctor told her that the noise of the device was too loud, and there was a burning smell observed.The doctor stopped the treatment, and the nurse gave the patient a mask and an ice compress.At this time, the nurse stated there were many wrinkles/lines on the patients's skin.The patient continued to experience burning pain about the left face, forehead and neck after the anesthetic effect was complete.The patient found there were many "brown bloodstains and scratches" on the skin.She visited the local hospital where she was given chloro-tetracycline ointment, and was told to apply it once that night, (b)(6) 2019, and once on the morning of (b)(6) 2019.The patient also used growth factor ointment once the night of (b)(6) 2019.As of (b)(6) 2019, the patient was still experiencing itchiness and pain on the neck, and pain at the touch of the face and forehead.Additional patient outcome information has been requested.It is unknown if there will be any permanent damage or scarring.

Manufacturer Narrative

According to thermage cpt safety risk assessment (sha-09-001 rev.H), shear force to the skin is a possible harm if the treatment tip has sharp edge.If the treatment tip produces any uncharacteristic tissue outcomes and/or shows visual signs of membrane breakdown during treatment, use of tip should be discontinued.If is important to the user to visually inspect the tip during treatment.No system or treatment information provided by the clinic.No product returned for evaluation.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is deemed necessary.The patient reported that the doctor told them that the noise of the device was too loud and there was a burning smell during treatment.It is unclear if the patient received a topical anesthetic or was completely sedated during treatment.Based on the available information, no causal factor can be determined, and no conclusion can be drawn.Requests have been made for device return.Should the product be received, further investigation will follow.The investigation is considered complete at this time.

• Brand Name: THERMAGE TIP
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL; 11720 n creek pkwy n, ste 100; bothell WA 98011
• MDR Report Key: 8333094
• MDR Text Key: 135946444
• Report Number: 3011423170-2019-00010
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/11/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR