Provox Brush Long XL 8425Recalls & reported problems
Atos Medical AB · Provox Brush is a single patient use device intended for cleaning Provox voice prostheses, for insertion of Provox Plug and Provox Vega Plug, for applying lubricant and anti-candida agents and for cleaning of fenestration holes on Provox LaryTubes. The product is intended for use by the patient. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 07331791015595), received between Feb 8, 2022 and Feb 8, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 8, 2022Break; Break
THIS IS THE EVENT DESCRIPTION RECEIVED FROM THE INITIAL REPORTER: DURING CLEANING, THE BRUSH CAME LOOSE FROM THE HANDLE ON (B)(6) 2022. HE THEN PULLED THE BRUSH OUT OF THE VP. QUESTIONS WERE ASKED BY ATOS MEDICAL TO BETTER UNDERSTAND THE EVENT. HOW LONG HAS THE USER BEEN ORDERING/USING THE PROVOX BRUSH PRODUCT? PATIENT HAS BEEN USING IT SINCE (B)(6) 2012. HOW MANY DAYS IS EACH BRUSH NORMALLY USED? 1 TO 2 WEEKS. HOW MANY TIMES PER DAY DOES THE USER NORMALLY USE THE BRUSH? 3 TIMES A DAY. HOW DOES THE USER CLEAN AND DRY THE BRUSH? BRUSH IS RINSED WITH WATER AND PLACED IN THE CUP TO DRY - BRUSH HEAD ON TOP. WHEN THE BRUSHES WEREN'T USED, HOW/WHERE WAS IS STORED? IN THE MIRROR CABINET IN THE BATHROOM, IN A CUP. WAS THE ATTACHED MANUAL (INCLUDED THE ILLUSTRATIONS) READ AND UNDERSTOOD IN FULL BY THE USER BEFORE USE OF THE PRODUCT? YES. THE ACTUAL BRUSH THAT BROKE - WAS THE BRUSH HEAD (A) OR BLUE HANDLE (B) BENDED BY THE USER? NO, ALWAYS APPLIED STRAIGHT. WAS THE ACTUAL BRUSH INSPECTED BEFORE USE RIGHT BEFORE THIS HAPPENED? YES. WHICH VOICE PROSTHESIS WAS USED? (NOT STATED IN FORM). PROVOX VEGA XTRASEAL 6 MM. DID THE USER EXPERIENCE PROBLEM CLEANING THE VP BEFORE IT BROKE? NO. CAN IT BE DE
Patient problems: Foreign Body In Patient
MAUDE report 13482245 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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