DreamWear Full DreamWear Full Mask w/Medium Frame w/Headgear, GlobalRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959045897), received between Mar 4, 2022 and Jun 7, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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 18, 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.

• InjuryJun 7, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT A DREAMWEAR FULL FACE USER'S FRONT TEETH TO MOVE AFTER USING THE FULL-FACE MASK. THE END USER STATES HE THINKS THE DAMAGE WAS DUE TO THE PRESSURE OF THE MASK ON HIS MOUTH WHICH CAUSED HIS TWO FRONT TEETH TO MOVE. THE USER HAS NOT YET SEEN THE DENTIST. THE USER CONTACTED HIS PROVIDER AND IS NOW USING A DIFFERENT MASK. THE USER STATES HE IS ALREADY MISSING ONE OF HIS TEETH NEAR THE SIDE/FRONT OF HIS MOUTH. THE PRESSURE OF THE MASK IS MAKING HIS TWO FRONT TEETH TO BECOME WOBBLY. THE MASK HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE DREAMWEAR FULL FACE MASK INSTRUCTIONS FOR USE WARN THE USER TO "DISCONTINUE USE AND CONSULT YOUR HEALTHCARE PROFESSIONAL IF ANY OF THE FOLLOWING SYMPTOMS OCCUR: TOOTH, GUM, OR JAW SORENESS. USE OF A MASK MAY AGGRAVATE AN EXISTING DENTAL CONDITION." THIS REPORT WILL BE FILED AS AN INITIAL FINAL REPORT. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: Tooth Loss

  MAUDE report 17080249 ↗
• MalfunctionMay 25, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  AN END USER ALLEGED THE MAGNETS IN A DREAMWEAR FULL FACE MASK AFFECTED HIS MEDTRONIC AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) WHEN THE MASK STRAP POPPED OFF, RESULTING IN THE MASK COMING IN CLOSE CONTACT WITH AND RESETTING THE AICD. THERE WAS NO REPORT OF SERIOUS OR PERMANENT INJURY, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE END USER DISCONTINUED USE OF THE DREAMWEAR MASK , WAS GIVEN A DIFFERENT MASK TO USE BY HIS PROVIDER, AND HAS HAD NO FURTHER INCIDENTS. THE MASK WAS NOT RETURNED TO THE MANUFACTURER. LABELING INCLUDED WITH THE MASK WARNS THE USER "THE HEADGEAR CLIPS AND MASK CUSHION CONTAIN MAGNETS. CONTACT YOUR HEALTHCARE PROVIDER BEFORE YOU USE THIS MASK. SOME MEDICAL DEVICES MAY BE AFFECTED BY MAGNETIC FIELDS. THE MAGNETIC CLIPS IN THIS MASK SHOULD BE KEPT AT LEAST 2 INCHES AWAY FROM ANY ACTIVE MEDICAL DEVICE WITH SPECIAL ATTENTION TO IMPLANTED DEVICES SUCH AS PACEMAKERS, DEFIBRILLATORS, AND COCHLEAR IMPLANTS. THE MANUFACTURER WILL CONTINUE TO MONITOR COMPLAINTS FOR TRENDS. NO FURTHER ACTION IS NECESSARY AT THIS TIME.

  Patient problems: Arrhythmia

  MAUDE report 14498622 ↗
• InjuryMar 4, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION FROM A USER WHO REPORTEDLY WENT INTO ARRHYTHMIA FOR ABOUT TWO HOURS AFTER WEARING THE DREAMWEAR FULL FACE MASK WITH MAGNETIC CONNECTIONS. USER REPORTED HE DID NOT GET ANY MEDICAL INTERVENTION AND HE FELT FINE AFTER A FEW HOURS. USER REPORTS HE NOW USES AN AMARA VIEW MASK WITHOUT ISSUES. USER ALSO STATES HE DOES NOT WANT TO SEND IN HIS OLD MASK. NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE DREAMWEAR INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING WARNINGS: THE HEADGEAR CLIPS CONTAIN MAGNETS. CONTACT YOUR HEALTHCARE PROFESSIONAL BEFORE YOU USE THIS MASK. SOME MEDICAL DEVICES MAY BE AFFECTED BY MAGNETIC FIELDS. THE MAGNETIC CLIPS IN THIS MASK SHOULD BE KEPT AT LEAST 2 IN. (50 MM) AWAY FROM ANY ACTIVE MEDICAL DEVICE WITH SPECIAL ATTENTION TO IMPLANTED DEVICES SUCH AS PACEMAKERS, DEFIBRILLATORS AND COCHLEAR IMPLANTS. DO NOT USE IN OR NEAR MAGNETIC RESONANCE IMAGING (MRI) EQUIPMENT. THIS REPORT WILL BE FILED AS AN INITIAL-FINAL REPORT. WE WILL CONTINUE TO MONITOR THESE COMPLAINTS REGARDING MAGNETS. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Arrhythmia

  MAUDE report 13670716 ↗