Face Applicator (Cheek Right) AG608275ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290016633542), received between Jul 27, 2021 and Feb 16, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2023Use of Device Problem; Use of Device Problem

  FULL THICKNESS (3RD STAGE) BURN ON RIGHT CHEEK.

  Patient problems: Burn(s)

  MAUDE report 16384841 ↗
• InjuryJul 27, 2021Use of Device Problem

  THE PATIENT WAS TREATED WITH EVOKE SYSTEM UTILIZING BOTH THE RIGHT AND LEFT CHEEK APPLICATORS. DURING THE TREATMENT TIME, THE PATIENT CALLED FOR ASSISTANCE AND COMPLAINT OF BURNED SENSATION IN HER RIGHT CHEEK. THE HEALTHCARE TEAM IMMEDIATELY STOPPED THE DEVICE OPERATION AND HAD THE PATIENT HOLD ICE TO THE AREA OF THE INCIDENT. PICTURES OF THE PATIENT TREATMENT AREA REVEALED A ROUND EXPOSED BURN ABOUT 2 CM IN DIAMETER, LOCATED AT THE SKIN PORTION IN CORRESPONDENCE WITH THE LEFT TMJ. MULTI-LAYERED TRANSDERMAL DAMAGE WITH TISSUE NECROSIS WAS EVIDENT. THE PATIENT WAS SENT FOR INJURY MANAGEMENT AND WAS UNDER A CARE OF A DERMATOLOGIST FOR WOUND MANAGEMENT AND HAS BEEN TO A BURN CLINIC. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR TESTING AND WAS SHOWN TO WORK SAFELY UNDER THE REQUIRED PERFORMANCE SPECIFICATIONS, NO DEVICE DEFECTS OR MALFUNCTIONS WERE DETECTED. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Full thickness (Third Degree) Burn; Skin Burning Sensation

  MAUDE report 12228102 ↗