DEKA SMARTXIDE M079R1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08057017760078), received between Nov 14, 2023 and Nov 14, 2023 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, EL. EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT VIA EMAIL FROM THE PATIENT IN WHICH SHE COMPLAINTS OF HYPOPIGMENTATION ON THE NECK AND FACE FOLLOWING A CO2 FRACTIONAL LASER TREATMENT. IN THE INITIAL COMMUNICATION RECEIVED FROM THE PATIENT IT IS NOT SPECIFIED THE ACTUAL MEDICAL DEVICE INVOLVED IN THE EVENT BUT THE PATIENT JUST SUPPOSED THAT THE DEVICE WAS A SMARTXIDE. PATIENT REPORTED THAT THE EVENT TOOK PLACE IN DATE (B)(6) 2022 AT (B)(6) IN (B)(6). BASED ON THE INFORMATION REPORTED ON THE PATIENT'S COMMUNICATION WE PROCEEDED BY CONTACTING THE CLINIC IN ORDER TO GATHER MORE DETAILED INFORMATION ON THE EVENT AND TO IDENTIFY THE ACTUAL DEVICE INVOLVED IN THE EVENT. THE DEVICE HAS BEEN IDENTIFIED AS A DEKA SMARTXIDE WITH DOT SCANNER (REF: M079R1 - S/N: (B)(6) - UDI: (B)(4) MANUFACTURED BY EL. EN. ELECTRONIC ENGINEERING SPA AD MARKETED IN THE USA WITH 510(K) NUMBER K072159. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON OCTOBER THE 18TH, 2023 BY EMAIL FROM THE PATIENT AND, ACCORDING TO 21 CFR PART 803 EVALUATED THE EVENT REPORTABLE BECAUSE WE HAVE ASSUMED THE LESIONS TO BE A PERMANENT IMPAIRMENT (ON THE SIDE OF CAUTION).

  Patient problems: Hypopigmentation

  MAUDE report 18132959 ↗