DreamWear Full DreamWear Full Mask Small, with Small-Medium Frame, GlobalRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959046276), received between Nov 9, 2022 and Nov 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• MalfunctionNov 9, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE MANUFACTURER RECEIVED A CALL FROM A DISTRIBUTOR ASKING ABOUT THE GUIDELINES FOR PATIENT USE WITH THE DREAMWEAR FULL FACE MASK AND A PACEMAKER. THE CALLER WAS DIRECTED TO REVIEW THE STATEMENT IN THE INSTRUCTION MANUAL. IT WAS STATED THAT THE USER'S DOCTOR HAS RECOMMENDED KEEPING THE MAGNETS 6-7INCHES FROM THE PACEMAKER. THE MANUFACTURER INSTRUCTED THE CALLER TO HAVE THE PATIENT FOLLOW PHYSICIAN RECOMMENDATIONS, AS THEY ARE FAMILIAR WITH THE SPECIFICATION OF THE PATIENT'S PACEMAKER DEVICE. 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 15760713 ↗