Provox TruTone Emote 7439Recalls & reported problems
Atos Medical AB · An electrolarynx is a battery-powered artificial larynx that is externally applied on undamaged skin and intended for use in the absence of the larynx or the inability to use the larynx to produce sound. · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07331791015830), received between Dec 4, 2024 and Dec 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device1
Patient problems
- Erythema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2024Defective Device; Defective Device
DEVICE IS SHOCKING PATIENT INTERMITTENTLY. ADDITIONAL INFORMATION RECEIVED 2024-11-13: THEY STATED THAT THE DEVICE SENT SHOCKS UP TO HER JAW AND IT WAS PAINFUL. THE DEVICE IS WORKING INTERMITTENTLY. THE PATIENT DID NOT SEEK MEDICAL ATTENTION, BUT THEY HAD A FOLLOW-UP DOCTORS APPOINTMENT WHERE THEY LOOKED AT THE SKIN AND IT WAS RED. THE PATIENT HAS STOPPED USING THE ELECTROLARYNX AND THE DEVICE IS ON ITS WAY BACK TO ATOS.
Patient problems: Erythema
MAUDE report 20843190 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.