DEKA SMARTXIDE TETRA M118C1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08057017760290), received between Apr 14, 2023 and Apr 14, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 16, 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.

• InjuryApr 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2023, EL. EN. ELECRTONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US IMPORTER, CARTESSA AESTHETICS, IN WHICH THEY INFORMED US TO HAVE RECEIVED FROM A CLINIC A COMPLAINT IN WHICH IT IS REPORTED THAT 3 PATIENT DEVELOPED LESIONS ON THE FACE FOLLOWING A DERMATOLOGICAL TREATMENT WITH THE DEVICE SMARTXIDE TETRA. THE EVENTS TOOK PLACE ALL IN THE SAME CLINIC WITH THE SAME DEVICE. THE ACTUAL DEVICE INVOLVED IN THIS EVENT IS A DEKA SMARTXIDE TETRA MANUFACTURED BY EL.EN. SPA AND MARKETED IN THE US WITH 510(K) NUMBER K180193. ALL THE THREE PATIENT'S LESIONS AND TREATMENT HAS BEEN EVALUATED. THE FIRST TWO HAS BEEN CONSIDERED REPORTABLE, ON THE SIDE OF CAUTION, CONSIDERING THEIR LESION AS SERIOUS INJURIES (FIRST DEGREE BURNS). THE THIRD PATIENT'S LESION HAS BEEN EVALUATED TO NOT BE SERIOUS INJURIES THAT WOULD HEAL PROPERLY WITH STANDARD POST-TREATMENT CARE (EVALUATION PERFORMED BY A PERSON QUALIFIED TO MAKE A MEDICAL JUDGEMENT). THE PRESENT REPORT WILL COVER THE EVENT RELATIVE TO PATIENT A. PATIENT IS A FEMALE, 34 YEARS OLD WITH SKIN TYPE III (FITZPATRICK SCALE). THE DAY AFTER THE TREATMENT THE PATIENT REPORTED FEELING TENDER AND WARM, BUT 48 HOURS LATER, REPOR

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16741830 ↗
• InjuryApr 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON MARCH THE 31ST 2023, EL. EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US IMPORTER, (B)(4), IN WHICH THEY INFORMED US TO HAVE RECEIVED FROM A CLINIC A COMPLAINT IN WHICH IT IS REPORTED THAT 3 PATIENT DEVELOPED LESIONS ON THE FACE FOLLOWING A DERMATOLOGICAL TREATMENT WITH THE DEVICE SMARTXIDE TETRA. THE EVENTS TOOK PLACE ALL IN THE SAME CLINIC WITH THE SAME DEVICE. THE ACTUAL DEVICE INVOLVED IN THIS EVENT IS A DEKA SMARTXIDE TETRA MANUFACTURED BY EL.EN. SPA AND MARKETED IN THE US WITH 510(K) NUMBER K180193. ALL THE THREE PATIENT'S LESIONS AND TREATMENT HAS BEEN EVALUATED. THE FIRST TWO HAS BEEN CONSIDERED REPORTABLE, ON THE SIDE OF CAUTION, CONSIDERING THEIR LESION AS SERIOUS INJURIES (FIRST DEGREE BURNS). THE THIRD PATIENT'S LESION HAS BEEN EVALUATED TO NOT BE SERIOUS INJURIES THAT WOULD HEAL PROPERLY WITH STANDARD POST-TREATMENT CARE (EVALUATION PERFORMED BY A PERSON QUALIFIED TO MAKE A MEDICAL JUDGEMENT). THE PRESENT REPORT WILL COVER THE EVENT RELATIVE TO PATIENT B. PATIENT IS A FEMALE, 34 YEARS OLD WITH SKIN TYPE II (FITZPATRICK SCALE). THE DAY AFTER THE TREATMENT THE PATIENT REPORTED FACE FEELING HOT, BUMPY TEXTURE, TIGHT, AND SWOLLEN. THE

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16741829 ↗