DEKA SMARTPERIO M128A1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08057017760528), received between Dec 11, 2024 and Dec 11, 2024 — 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.

• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN DATE NOVEMBER THE 13TH, 2024 OUR US IMPORTER, (B)(4), INFORMED US OF AN ADVERSE EVENT IN WHICH THE PATIENT IS COMPLAINING OF SEVERE PATHOLOGIES THAT AROSE SINCE THE TREATMENT PERFORMED ON HIM FOR TEMPORO MANDIBULAR JOINT (TMJ) TREATMENT WITH THE DEVICE SMARTPERIO AND ITS ACCESSORY BIOSTIMUL. IN THE NARRATIVE PROVIDED IT IS REPORTED THE FOLLOWING: IN DATE NOVEMBER THE 13TH, 2024 OUR US IMPORTER (B)(4), INFORMED US THAT THE CLINIC (B)(6) (IN THE PERSONS OF DR. (B)(6)) HAS BEEN CONTACTED BY A PATIENT THAT COMPLAINTS TO HAVE BEEN DIAGNOSED WITH ALS (AMYOTROPHIC LATERAL SCLEROSIS) FOLLOWING THE HILT LASER TREATMENT. IN THE INFORMATION PROVIDED THE CLINIC FORWARDED INFORMATION ABOUT THE DEVICE INVOLVED AND THE SUBSEQUENT COMMUNICATION HELD WITH THE PATIENT. NO OFFICIAL DOCUMENT CONFIRMING THE DIAGNOSIS OF ALS HAS BEEN SHARED BY THE PATIENT NOR THROUGH THE LAWYERS OF THE PARTIES. THE ONLY MEDICAL REPORT SHARED WAS THE BLOODWORK OF THE PATIENT THAT CANNOT CONFIRM THE PATHOLOGIES COMPLAINED. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS A DEKA SMARTPERIO WITH REF M128A1 WHICH IS MARKETED IN THE US WITH 510(K) NUMBER K213658. THE DEVICE IS EQUIPPED WITH ITS ACCESSORY BIOSTIMUL (EMITS IN THE

  Patient problems: Limb Pain; Loss of Range of Motion; Nerve Damage; Numbness; Unspecified Heart Problem

  MAUDE report 20902810 ↗