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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00606959046047), received between Nov 9, 2022 and Apr 2, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2024Leak/Splash; Leak/Splash

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PATIENT STATES HIS MASK HAS AN AIR LEAKAGE FROM THE LIPS WHEN HE WEARS IT. PATIENT ALSO ALLEGES THAT HE WAKES UP WITH DRY MOUTH, BLOATING AND DISCOMFORT IN THE STOMACH WITH DRYNESS IN HIS EYES. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Discomfort; Dry Eye(s); Dry Mouth

  MAUDE report 19017235 ↗
• InjuryNov 10, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION THAT A USER WITH ORTHODONTIC BRACES IN HIS MOUTH EXPERIENCED LOWER JAW GROWTH FROM USING THE DREAMWEAR FULL FACE MASK WITH MAGNETIC CLIPS. THE USER HAS SINCE HAD A TONSILLECTOMY, THE BRACES WERE REMOVED  AND NO LONGER USES A CPAP. THE USER'S MOTHER STATES HE NOW NEEDS A SECOND SET OF ORTHODONTIC BRACES AND JAW SURGERY DUE TO HIS LOWER JAW GROWING OUT ALLEGEDLY DUE TO THE MAGNETS. REQUESTED THE RETURN OF THE MASK FOR INVESTIGATION. TO DATE, NO MASK HAS BEEN RETURNED. THE INVESTIGATION IS ON-GOING. A FOLLOW UP FINAL WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15770548 ↗
• MalfunctionNov 9, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT AN END USER WAS ASKING IF THERE WAS ANY DOCUMENTATION OF TESTING WITH THE DREAMWEAR FULL FACE MASK AND A PATIENT WHO HAS A PACEMAKER. THE USER WAS INFORMED THAT THE MANUAL STATES TO KEEP THE MASK 2 INCHES AWAY FROM THE PACEMAKER AND IT WAS SUGGESTED THAT THE USER CONTACT HIS CARDIOLOGIST WITH ANY CONCERNS AND TO STOP USING THE MASK UNTIL HE DOES SO. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO PRODUCT WILL BE RETURNED FOR INVESTIGATION. 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 SIMILAR ISSUES. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760843 ↗
• MalfunctionNov 9, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT THE DREAMWEAR FULL FACE MASK WITH MAGNETIC CLIPS WHILE USING WITH A PACEMAKER. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER HAS NOT RECEIVED THE PRODUCT 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, AN ADDITIONAL REPORT WILL BE FILED. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760073 ↗