Provox NID 20, 6 mm 7111Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07331791000331), received between Jun 14, 2022 and Jun 14, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THIS IS THE EVENT DESCRIPTION RECEIVED FROM THE INITIAL REPORTER: PATIENT WAS IN HOSPITAL FOR ABOUT 1.5 WEEKS, CAME HOME, HAD ADDITIONAL PROBLEMS SO HAD TO GO BACK IN. IT TURNED OUT THE VALVE WAS LEAKING AND CAUSED ASPIRATION PNEUMONIA IN WHICH SHE HAD TO BE PUT ON ANTIBIOTICS. SEVERAL FOLLOW-UP QUESTIONS HAVE BEEN ASKED AND WERE ANSWERED BY THE CUSTOMER SUPPORT REPRESENTATIVE SINCE IT WAS NOT POSSIBLE TO REACH THE USER. THE USER ONLY HAD THE PROSTHESIS FOR ONE DAY. THE USER WENT TO HOSPITAL FOR OTHER REASONS AND THE DOCTOR DIAGNOSED PNEUMONIA DUE TO THE LEAKING PROSTHESIS. THE NID WAS REPLACED WITH ANOTHER VP SO THAT A PLUG CAN BE USED. THE USER IS OUT OF THE HOSPITAL AND HAS ORDERED ANOTHER NID, WHICH THE USER IS NORMALLY USING. DESCRIPTION OF THE PRODUCT: PROVOX NID IS A NON-INDWELLING VOICE PROSTHESIS FOR PATIENTS WHO ARE CAPABLE OF HANDLING THE EXCHANGE AND MAINTENANCE OF A VOICE PROSTHESIS INDEPENDENTLY OF A CLINICIAN OR PHYSICIAN. THE PROSTHESIS IS AVAILABLE IN TWO OUTER SHAFT DIAMETERS (17 AND 20 FRENCH) AND SEVERAL LENGTHS. THE VOICE PROSTHESIS IS SEATED IN A PUNCTURE IN THE WALL BETWEEN ESOPHAGUS AND TRACHEA.

  Patient problems: Pneumonia

  MAUDE report 14684371 ↗