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

Lot Number 222

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Blister (4537)

Event Type  Injury  

Manufacturer Narrative

The treatment tip used in this case was discarded before the event was reported and is therefore not available for evaluation.Based on available information no conclusion can be drawn and no root cause can be established.

Event Description

A clinic reported a patient experienced blisters on their face three days post a thermage cpt treatment.Additional information has been requested, but not yet received.

Manufacturer Narrative

The treatment tip used in this case was discarded before the event was reported and is therefore not available for evaluation.Based on available information no conclusion can be drawn and no root cause can be established.

Event Description

A clinic reported a patient experienced blisters on their face three days post a thermage cpt treatment.Additional information has been requested, but not yet received.

Manufacturer Narrative

Additional clinical information has been received and evaluated by a medical professional.It has been determined there was no serious injury experienced in this case, therefore this is no longer considered a serious injury.

Event Description

Additional clinical information has been received and evaluated by a medical professional.It has been determined there was no serious injury experienced in this case, therefore this is no longer considered a serious injury.

• Brand Name: THERMAGE CPT SYSTEM
• Type of Device: ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
• Manufacturer (Section D): SOLTA MEDICAL INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC; 11720 n creek parkway n; suite 100; bothell WA 98011
• Manufacturer Contact: jennifer gamet ; 1400 goodman st n; rochester, NY 14609
• MDR Report Key: 13359784
• MDR Text Key: 286019452
• Report Number: 3011423170-2022-00005
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K132431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other