Prosomnus IA MonogramRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00863039000416), received between Sep 25, 2020 and Dec 15, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PROSOMNUS RECEIVED A COMPLAINT FROM DENTIST REPORTING ABOUT A PATIENT ASPIRATING A BROKEN PIECE OF THE DEVICE DURING USE. PATIENT HAD TO UNDERGO ENDOSCOPY IN EMERGENCY DEPARTMENT TO REMOVE THE BROKEN FRAGMENT FROM THE PATIENT'S RIGHT LUNG. DENTIST ALSO CONFIRMED THAT THERE WAS NO FURTHER COMPLICATIONS TO THE PATIENT DUE TO THIS INCIDENT. PATIENT WANTS TO CONTINUE THE TREATMENT WITH PROSOMNUS DEVICE.

  Patient problems: Aspiration/Inhalation

  MAUDE report 15992887 ↗
• MalfunctionJun 14, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  PATIENT'S TOOTH #7 CHIPPED OFF DURING HER DELIVERY APPOINTMENT . THE DOCTOR REPORTED THAT SHE TRIED TO ADJUST THE TRAY, BUT IT BROKE IN HALF IN THE #7 AREA.

  Patient problems: Tooth Fracture

  MAUDE report 14682758 ↗
• InjurySep 25, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  DENTIST REPORTED THAT THE PATIENT BROKE TOOTH #14, WHICH HAD A TWO SURFACE COMPOSITE IN IT WHILE WEARING THE DEVICE. THE CROWN WAS CEMENTED AND THE DENTIST TEMPORARILY ADJUSTED THE DEVICE AND REPORTED THAT IT WORKED FAIRLY WELL. HOWEVER, THE PATIENT BROKE TEETH #5 AND #23 SOON AFTER. UPON FURTHER QUESTIONING, THE DENTIST REPORTED THAT THE CROWN WAS CEMENTED AND ANOTHER ORAL DEVICE WAS MADE FOR THE PATIENT. THE PATIENT DID NOT NEED ANY MEDICAL ATTENTION.

  Patient problems: Tooth Fracture

  MAUDE report 10589316 ↗