SOLTA MEDICAL INC THERMAGE FLX (TG-3A) SYSTEM AND ACCESSORIES; ELECTROSURGICAL,CUTTING & COAGULATION & ACC.
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Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Burn(s) (1757); Scarring (2061); Skin Discoloration (2074)
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Event Date 09/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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Follow up with the distributor indicates that they have not sold this doctors office a thermage product.They are unsure how it was obtained.Based on the available information, no causal factors can be determined, and no conclusions can be drawn.
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Event Description
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A patient reported that post their thermage treatment they experienced a burn on their jaw area.The physician applied ice and told the patient the burned area will fade.The day after the procedure the patient reported feeling of protrusion of the area.Following-up with the patient, she indicated there is some hyperpigmentation remaining with some depressed scarring.No other treatment, besides the ice treatment was provided.No photographs are available.Additional treatment details have been requested, but not yet received.
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Manufacturer Narrative
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Medical and product information were requested but not received.Product was not returned for evaluation and a lot number was not provided.According to thermage flx user manual, burns are a known possible side effect during a thermage flx treatment.The procedure produces heating in the upper layers of the skin and may cause burns and subsequent blister and scab formation.There is a small chance of scar formation.Application of topical steroidal or antibiotic preparations may be of benefit.In the rare instance of a burn that results in a scar, the scar will most likely be very small and respond readily to removal with a laser device.No additional information or product reviewed from the reported treatment site.Based on the lack of available information, no causal factors can be determined, and no conclusions can be drawn.
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Search Alerts/Recalls
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