ThermiRFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817371020014), received between Nov 17, 2023 and Nov 17, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2023Human-Device Interface Problem; Human-Device Interface Problem

  PHYSICIAN'S OFFICE ACCT# (B)(4) REPORTED A BURN ON (B)(6) 2021 TO SALES REPRESENTATIVE. THERMITIGHT PROCEDURE WAS PERFORMED ON (B)(6) 2023 ON THE PATIENT'S NECK AND SUBMENTAL AREA AFTER SUBMENTAL LIPSUCTION. THE TREATMENT SET TEMPERATURE WAS 65C, AND DURING TREATMENT THE READINGS WERE BETWEEN 65-67C. THE SURGICAL TECHNICIAN MONITORING THE "EXTERNAL TEMP" READ A TEMPERATURE RANGE OF 35-40C. DURING TREATMENT THERE WAS NO INDICATION OF BURNS, SKIN WAS WARM AND PERFUSING APPROPRIATELY. TREATMENT TIME OF THE PROCEDURE WAS 20 MINUTES. AFTER THE TREATMENT WHILE CLEANING, IT WAS NOTICED THAT THE PATIENT'S SKIN WAS PINK AND PEELING ON THE LEFT SIDE OF THE PATIENT'S NECK BUT DID NOT EXHIBIT OPEN AREAS INDICATIVE OF COOL COMPRESS AND VASELINE. THE PATIENT WAS "WRAPPED" PER USUAL POST PROCEDURE. THE DAY FOLLOWING THE PROCEDURE, THE PATIENT RETURN WITH SIGNIFICANT BLISTERING ON RIGHT SIDE OF NECK AND OPEN AREAS ON LEFT SIDE OF THE NECK AND BURNS IN THE SUBMENTAL AREA. IMAGES OF THE PATIENT WAS PROVIDED, OFFICE PERSONNEL NOTED THAT THE PROTOCOL HAS BEEN FOLLOWED, AND THAT THERE WERE TWO PEOPLE MONITORING TEMPERATURE WITH NO INDICATION THAT THE SKIN WAS "TOO HOT" CITING CONCERNS ABOUT THE INFRARE

  Patient problems: Burn(s)

  MAUDE report 18165464 ↗