Provox Brush 7204Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07331791000775), received between Apr 5, 2017 and Mar 12, 2024 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE BRUSH HEAD CAME AWAY FROM THE HANDLE AND WHEN DOWN THE PATIENT'S THROAT WHICH RESULTED IN A 9 HOUR STAY AT THE HOSPITAL FOR THE PATIENT. FOLLOW-UP QUESTIONS WERE SENT TO RETRIEVE MORE INFORMATION ABOUT THE EVENT AND THE FOLLOWING INFORMATION WAS GATHERED: THE BRUSH HAD BEEN USED A FEW TIMES BEFORE AND HAD NOT BEEN USED FOR LONGER THAN A MONTH (MAXIMAL USAGE TIME). THE BRUSH DID NOT APPEAR DAMAGED BEFORE USE AND HAD ONLY BEEN CLEANED WITH WARM WATER. THE PATIENT HAD NOT BEEN USING THE BRUSH TO CLEAN THE VOICE PROSTHESIS, BUT TO CLEAR MUCUS AROUND THE INSIDE OF THE STOMA. WHEN DOING SO THE PART OF THE BRUSH WITH METAL WIRE AND BRISTLES ("BRUSH HEAD") DETACHED FROM THE MOULDED PLASTIC HANDLE AND FELL DOWN INTO THE PATIENT'S TRACHEA. THE BRUSH HEAD COULD BE RETRIEVED BY HOSPITAL PERSONNEL WITHOUT ANY ISSUES SINCE IT HAD NOT GONE DOWN VERY FAR INTO THE PATIENT'S TRACHEA. THE PATIENT'S ATTITUDE TO USE THE BRUSH IS NOW NOT AS POSITIVE AS BEFORE THE INCIDENT. DESCRIPTION OF THE PRODUCT: THE PROVOX BRUSH IS A DEVICE HELPING TO CLEAN PROVOX VOICE PROSTHESES OR FENESTRATION HOLES IN LARYTUBE OR CAN BE USED FOR APPLICATION OF FLOUROSILICONE OIL OR ANTI-CANDIDA MEDICATION INTO PROVOX VOICE

  Patient problems: Aspiration/Inhalation

  MAUDE report 18889075 ↗
• MalfunctionMar 1, 2022Break; Break

  THIS IS THE EVENT DESCRIPTION RECEIVED FROM THE INITIAL REPORTER: PATIENT HAS HAD THE BRUSHES SINCE (B)(6) 2021, SHE USED ONE OF THE BRUSHES TO CLEAN HER VOICE PROSTHESIS AND AS SHE REMOVED IT FROM HER STOMA THE WIRE PART OF THE BRUSH DETACHED FROM THE PLASTIC ARM OF THE BRUSH. THE PATIENT SAID IT WAS ONLY THIS BRUSH THAT IT HAPPENED TO BUT AS ADVISED SHE HAS BEEN USING THE BRUSH A LITTLE LONGER THAN THE RECOMMENDED TIME FRAME. SEVERAL FOLLOW-UP QUESTIONS WERE SENT BUT UNFORTUNATELY REACHING THE USER IS DIFFICULT. DESCRIPTION OF THE PRODUCT: PROVOX BRUSH IS A DEVICE INTENDED FOR CLEANING OF PROVOX VOICE PROSTHESES IN-SITU. CLEANING IS RECOMMENDED TWICE A DAY AND AFTER EACH MEAL. THE VOICE PROSTHESIS IS SEATED IN A PUNCTURE IN THE WALL BETWEEN ESOPHAGUS AND TRACHEA. THE BRUSH IS INTENDED FOR SINGLE PATIENT RE-USE AND IS INTENDED FOR BOTH HOME AND CLINICAL USE BY PATIENT OR CLINICIAN. MAXIMUM USE 30 DAYS.

  Patient problems: Foreign Body In Patient

  MAUDE report 13635611 ↗
• MalfunctionFeb 16, 2022Break; Break

  THIS IS THE EVENT DESCRIPTION RECEIVED FROM THE INITIAL REPORTER: "WHEN CLEANING THE VOICE PROSTHESIS, THE BRUSH BROKE OFF THE HANDLE. THE PATIENT WAS ABLE TO REMOVE THE BRUSH FROM THE VOICE PROSTHESIS HERSELF. I HAVE ASKED TO RETURN THE BRUSH, BUT DON'T KNOW IF THE CUSTOMER IS IN A POSITION TO DO SO. IT'S AN ELDERLY PATIENT. THE PATIENT IS VERY SHOCKED BY THIS INCIDENT. FOLLOW-UP QUESTIONS WERE SENT BY ATOS MEDICAL. ANSWERS RECEIVED DATE 2022-01-26: HOW LONG WAS THE ACTUAL PRODUCT (THAT BROKE) USED? 4 WEEKS. HOW LONG HAS THE USER BEEN USING THE PROVOX BRUSH PRODUCTS? (IN GENERAL) SHE HAS BEEN USING THE PRODUCT FOR 22 YEARS. HOW MANY DAYS IS EACH BRUSH NORMALLY USED? 1 MONTH. HOW MANY TIMES PER DAY DOES THE USER NORMALLY USE THE BRUSH? 2 TIMES A DAY, EXCEPT WHEN HAVING A COLD. HOW DOES THE USER CLEAN AND DRY THE BRUSH? BRUSH IS CLEANED WITH LUKEWARM WATER. WHEN THE BRUSHES WEREN'T USED, HOW/WHERE WAS IS STORED? IN A CLOTH, IN A GLASS. WAS THE ATTACHED MANUAL (INCLUDED THE ILLUSTRATIONS) READ AND UNDERSTOOD IN FULL BY THE USER BEFORE USE OF THE PRODUCT? SHE HAS BEEN USING FOR 22 YEARS, I DON'T THINK SHE USES THE MANUAL. THE ACTUAL BRUSH (THAT BROKE) - WAS THE BRUSH HEAD OR BLUE HAND

  Patient problems: Foreign Body In Patient

  MAUDE report 13542365 ↗
• MalfunctionSep 23, 2021Break; Break

  THIS IS THE EVENT DESCRIPTION RECEIVED FROM THE INITIAL REPORTER: THAT PATIENT HAD THE INCIDENT THAT THE TIP OF PROVOX BRUSH BROKE AND ALMOST FELL INTO HIS WINDPIPE BUT IT STUCK TO TUNICA MUCOSA TRACHEAE SO IT DID NOT FALL DEEP INSIDE THE BRONCHUS. (THIS HAPPED AT NIGHT) HE WENT TO AN EMERGENCY ROOM AND A DOCTOR TOOK THE BRUSH TIP OUT WITH A FORCEPS. THE DOCTOR TOOK A LOOK AT INSIDE HIS BIFURCATION OF TRACHEA VERY CAREFULLY BY USING MICROSCOPE BUT ANY FOREIGN MATTERS WERE FOUND INSIDE, SO HE LEFT THE HOSPITAL WITHOUT HAVING OTHER TREATMENTS. THE FALLEN BRUSH TIP IS CURRENTLY KEPT AT THE HOSPITAL. ATOS REQUESTED THE HOSPITAL TAKING PICTURES OF THE BRUSH TIP AND SEND THEM TO ATOS SALES REP. WE ARE CURRENTLY CONFIRMING IF THE PATIENT HAS ANY FURTHER HEALTH ISSUES CAUSED BY THIS INCIDENT. DESCRIPTION OF THE PRODUCT: PROVOX BRUSH IS A DEVICE INTENDED FOR CLEANING OF PROVOX VOICE PROSTHESES IN-SITU. CLEANING IS RECOMMENDED TWICE A DAY AND AFTER EACH MEAL. THE VOICE PROSTHESIS IS SEATED IN A PUNCTURE IN THE WALL BETWEEN ESOPHAGUS AND TRACHEA. THE BRUSH IS INTENDED FOR SINGLE PATIENT RE-USE AND IS INTENDED FOR BOTH HOME AND CLINICAL USE BY PATIENT OR CLINICIAN. MAXIMAL USE 30 DAYS.

  Patient problems: Foreign Body In Patient

  MAUDE report 12518731 ↗
• MalfunctionJul 5, 2021Break; Break

  USER REPORTS THAT THE BRUSH HEAD BROKE OFF RIGHT BEFORE THE HANDLE PART BEGINS, THROAT STARTING TICKLING AND COUGHED OUT THE BRUSH HEAD THROUGH THE STOMA. THE BRUSHES WERE USED APPROX. 4 WEEKS. FOLLOW-UP QUESTIONS/ANSWERED BY USER Q WAS IT ONE OR TWO BRUSHES THAT BROKE? A TWO BRUSHES BROKE. Q PATIENT HURT OR SCARED? A I WAS NOT HURT, BUT I FELT SCARED AND UNCOMFORTABLE. Q WHICH INSTRUCTION HAVE YOU FOLLOWED TO USE THE BRUSH A I FOLLOWED THE INSTRUCTION MANUAL. Q WAS THE BRUSH THE NEW OR THE OLD DESIGN? A IT WAS THE NEW DESIGN. Q WAS THE ATTACHED MANUAL READ AND UNDERSTOOD (INCLUDED THE ILLUSTRATIONS) IN FULL BY THE USER BEFORE USE? A YES, THE MANUAL WAS READ AND UNDERSTOOD. Q WAS THE BLUE HANDLE BENDED BY THE USER? A NO, I DID NOT BEND THE BLUE HANDLE PART IN ANY WAY. Q WAS THE BRUSH HEAD BENDED BY THE USER? A NO, I DID NOT BEND THE BRUSH HEAD PART IN ANY WAY. Q WAS THE COMPLETE BRUSH VISUALLY INSPECTED BEFORE EACH USE BEFORE IT SNAPPED OFF? A YES, IT WAS INSPECTED VERY CAREFULLY AND EVERY TIME BEFORE AND AFTER EACH USE. Q CAN IT BE DESCRIBED IN MORE DETAIL WHERE THE BRUSH HEAD FELL OFF? A THE BRUSH HEAD FELL OFF RIGHT BEFORE HANDLE PART B BEGINS. Q CAN IT BE DESCRIBED IN MORE DETA

  Patient problems: Foreign Body In Patient

  MAUDE report 12116307 ↗
• MalfunctionJan 26, 2021Material Rupture; Material Rupture

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE INITIAL REPORTER: THE PATIENT WAS CLEANING HIS VOICE PROSTHESIS AND THE BRUSH HEAD SNAPPED OFF INSIDE THE VOICE PROSTHESIS AND HAD TO BE REMOVED WITH A TWEEZER. NO EFFECT ON VP. USED BRUSHES OUT OF SAME PACK AND HAD NO PROBLEM. DESCRIPTION OF THE PRODUCT: PROVOX BRUSH IS A DEVICE INTENDED FOR CLEANING OF PROVOX VOICE PROSTHESES IN-SITU. CLEANING IS RECOMMENDED TWICE A DAY AND AFTER EACH MEAL. THE VOICE PROSTHESIS IS SEATED IN A PUNCTURE IN THE WALL BETWEEN ESOPHAGUS AND TRACHEA.

  Patient problems: Foreign Body In Patient

  MAUDE report 11228620 ↗
• MalfunctionNov 12, 2020Material Rupture; Material Rupture

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE INITIAL REPORTER: PATIENT REPORTED THAT SHE TOOK A NEW PROVOX BRUSH OUT OF THE BAG ON SATURDAY NIGHT (B)(6) 2020 (SHE SAID IT WAS THE LAST ONE OUT OF THE PACK OF 6-LOT 1912004). SHE SAID IT WAS THE PREVIOUS STYLE OF BRUSH AND SHE WAS VERY FAMILIAR WITH USING THIS BRUSH. SHE SAID SHE INSPECTED THE BRUSH BECAUSE SHE HAD PREVIOUSLY HAD THE BRUSH TIP BE LOOSE WHEN SHE GOT THEM OUT OF THE BAG. SHE SAID THAT SHE REPORTED THE LOOSE WIRE TIP A YEAR AND A HALF AGO AND THAT NEW BRUSHES WERE SENT TO HER. SHE STATED THAT EVER SINCE THAT EXPERIENCE SHE ALWAYS CHECKS THE NEW ONES. SHE SAID SHE DID NOT NOTICE ANYTHING OUT OF THE NORM WITH THE NEW BRUSH ON SATURDAY NIGHT WHEN SHE USED IT TO CLEAN HER VOICE PROSTHESIS. SHE SAID WHEN SHE WENT TO CLEAN HER TEP THE NEXT MORNING (B)(6) 2020 AROUND 9:45 AM BEFORE CHURCH IS WHEN THE EVENT OCCURRED. SHE SAID SHE PUT THE BRUSH INTO THE TEP AND WHEN SHE PULLED IT OUT SHE NOTICED THE WHOLE WIRE TIP WAS MISSING. SHE HAD HER NEIGHBOR LOOK IN HER STOMA AND SHE COULD SEE THE WIRE TIP IN HER TRACHEA BUT WAS UNABLE TO RETRIEVE IT. SHE WENT TO ST. ELIZABETH'S HOSPITAL BUT THEY RECOMMENDED SHE GO TO (B)(6) FOR MORE

  Patient problems: Foreign Body In Patient

  MAUDE report 10828421 ↗
• MalfunctionFeb 6, 2020Material Rupture; Material Rupture

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE INITIAL REPORTER: THE PATIENT REPORTS THAT THE BRUSH HEAD OF THE PROVOX BRUSH REF 7204 BROKE OFF AND FELL INTO HER WINDPIPE, WHICH SHE TOOK OUT INDEPENDENTLY. ADDITIONAL QUESTIONS WAS ASKED TO THE PATIENT VIA A SALES REP. WHEN EXACTLY DID THE INCIDENT HAPPEN? BEFORE CHRISTMAS, THE PATIENT COULDN'T GIVE ME AN EXACT DATE. DID THE INCIDENT AFFECT YOUR HEALTH (BREATHING PROBLEMS, BLEEDING, ...)? NO, SHE HAD NO HEALTH PROBLEMS. COULD YOU DESCRIBE THE COURSE OF THE INCIDENT AGAIN IN DETAIL? SHE USED THE BRUSH AS ALWAYS, BUT THE BRUSH WAS USED FOR A PERIOD OF 4-5 WEEKS WITH DAILY USE (THE CHANGE IS PLANNED EVERY 2 WEEKS), IT NOT ONLY CLEANS THE CANNULA BUT ALSO GOES WITH THE BRUSH INTO IT TRACHEA TO REMOVE MUCUS OR SECRETIONS. SHE HERSELF DOES NOT BEND ON THE BRUSH, SHE SAID THAT THE BRUSH IS BENT DUE TO CLEANING AND BENDS ON THE WIRE. WHEN SHE FOUND THAT THE BRUSH HEAD WAS NO LONGER THERE AND SHE HAD A STRANGE FEELING IN THE WINDPIPE, SHE TOOK THE BARK TWEEZERS AND REMOVED THE FOREIGN BODY IN A SHORT TIME. DID THE USER READ THE MANUAL BEFORE USE? NO, BECAUSE THE PATIENT HAS BEEN USING THE BRUSHES FOR 16 YEARS AND HAS NEVER HAD ANY PROBLE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9676015 ↗
• MalfunctionApr 11, 2019Material Rupture; Material Rupture

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE INITIAL REPORTER: CLINICIAN REPORTED PATIENT WAS USING THE BRUSH TO REMOVE A MUCUS PLUG AND THE BRUSH TIP FELL OFF INTO THE TRACHEA. PATIENT WAS ABLE TO REMOVE WITH TWEEZERS. DESCRIPTION OF THE PRODUCT: PROVOX BRUSH IS A DEVICE INTENDED FOR CLEANING OF PROVOX VOICE PROSTHESIS IN-SITU. CLEANING IS RECOMMENDED TWICE A DAY AND AFTER EACH MEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503135 ↗
• InjuryDec 18, 2018Material Rupture; Material Rupture

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE INITIAL REPORTER: WHEN CLEANING THE VOICE PROSTHESIS, THE BRUSH HEAD IS BROKEN OFF THE BRUSH AND PASSED THROUGH THE SP INTO THE TRACHEA. CUSTOMER HAD TO GO TO THE HOSPITAL. BRUSH HEAD WAS REMOVED BY BRONCHOSCOPE. ADDITIONAL QUESTIONS POSED BY THE INVESTIGATOR TO THE PATIENT. WHEN DID THE INCIDENT OCCUR? REPLY: THE INCIDENT OCCURED ON (B)(6) 2018. THE CUSTOMER WAITED TO INFORM THE ATOS SALES REP ABOUT THE INCIDENT UNTIL (B)(6) 2018. DID THE INCIDENT HARM YOU IN ANY WAY (PROBLEMS WITH BREATHING, BLEEDING, ETC.)? REPLY: NO PROBLEMS BREATHING, NO BLEEDING. THE BRUSH HEAD WAS STUCK IN THE TRACHEA CLOSE TO THE VOICE PROSTHESIS. IT WAS REMOVED BY A CLINICIAN USING AN ENDOSCOPE. COULD YOU DESCRIBE IN DETAIL HOW THE INCIDENT CAME TO BE? REPLY: THE VOICE PROSTHESIS WAS CLEANED IN THE MORNING. THE BRUSH HEAD BROKE DURING THE CLEANING PROCESS. DID YOU BEND THE BRUSH? IF YES, WHERE? REPLY: NO. DID YOU VISUALLY INSPECT THE BRUSH BEFORE USING IT? REPLY: YES. YOU TOLD YOUR SALES REP ((B)(6), ATOS MEDICAL) THAT A SIMILAR PROBLEM OCCURRED IN 2016. WHAT HAPPENED BACK THEN? REPLY: SOME BRUSH FILAMENTS LOOSENED FROM THE BRUSH HEAD. DESCRIPTION OF THE P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8172945 ↗
• InjuryAug 30, 2018Material Rupture; Material Rupture

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE INITIAL REPORTER: ACCORDING TO CUSTOMERS IN THE NORMAL, REGULAR CLEANING OF THE VOICE PROSTHESIS - BREAKING OFF OF THE BRUSH HEAD. NO DAMAGE TO THE CUSTOMER! LOT INCOMPREHENSIBLE. DESCRIPTION OF THE PRODUCT: PROVOX BRUSH IS A DEVICE INTENDED FOR CLEANING OF PROVOX VOICE PROSTHESIS IN-SITU. CLEANING IS RECOMMENDED TWICE A DAY AND AFTER EACH MEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832494 ↗
• MalfunctionNov 27, 2017Material Rupture; Material Rupture

  WE HAVE RECEIVED A COMPLAINT FROM UNIVERSITY HOSPITAL OF (B)(6) REGARDING A BROKEN PROVOX BRUSH. THE PATIENT WHO HAS BEEN USING THIS PROVOX BRUSH SAID THAT SHE HAD NOT BENDED THE BRUSH. THE PROVOX BRUSH BROKE IN THE PROVOX PROSTHESIS BUT THE PATIENT TOOK THE BROKEN PART OR THE TIP OF THE BRUSH AWAY WITH A FORCEPS. THE SITUATION WAS SCARY AND THE PATIENT WAS FRIGHTENED OF THE SITUATION. EVERYTHING WENT FINE BUT THE MISSING PIECE COULD HAVE ENDED UP IN THE LUNGS OR ESOPHAGUS. ADDITIONAL INFO: THE PROSTHESIS USED WAS PROVOX VEGA 8MM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7058457 ↗
• MalfunctionJun 29, 2017Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE ATOS MEDICAL LOCAL REPRESENTATIVE: THE PATIENT REPORTS THAT SHE ASPIRATED THE METAL/BRUSH PART OF THE TEP BRUSH WHILE CLEANING HER TEP. SHE REPORTS IT BEING IN THE LUMEN OF THE TEP AND WHEN SHE PULLED IT OUT THE METAL PART WITH THE BRISTLES FELL OFF OF THE BRUSH AND INTO HER AIRWAY. SHE REPORTED THAT THE BRUSH WAS GIVEN TO HER BY HER SLP ((B)(6)) APPROXIMATELY 2 MOS. PRIOR TO THE EVENT. SHE LEANED OVER AND WAS ABLE TO COUGH THIS PIECE OF THE BRUSH OUT OF HER AIRWAY. NONE OF THE PARTS WERE KEPT TO BE EVALUATED. THE SLP DOES HAVE THE LOT NUMBER AND THE PACKS OF BRUSHES SHE RECENTLY ORDERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6676284 ↗
• MalfunctionApr 5, 2017Break; Detachment Of Device Component; Component Falling; Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  WE HAVE RECEIVED A COMPLAINT FROM (B)(6) MEDICAL CENTRE IN (B)(6) REGARDING A BROKEN PROVOX BRUSH. CLEANING BRUSH BROKE WHILE CLEANING THE PROSTHESIS AND FELL INTO THE LEFT BRONCHUS. ATTEMPTED TO LOCATE THE BROKEN ITEM BUT NO OBJECT WAS FOUND INTO THE SECONDARY BRONCHUS - FLEXIBLE ENDOSCOPE (BRONCHOSCOPY) CANNOT PASS INTO BRONCHIOLES. DUE TO INFECTION (WORSENING), CT-SCAN WAS DONE AT (B)(6) 2014 LOCATING THE BROKEN BRUSH IN THE LEFT POSTEROBASAL BRONCHIOLE - WHICH NECESSITATE A LEFT LOWER LOBECTOMY WHICH DONE AT (B)(6) 2017.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient; Unspecified Infection

  MAUDE report 6459884 ↗