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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959046320), received between Mar 4, 2022 and Mar 4, 2022 — classified as 1 malfunction.

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

• MalfunctionMar 4, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION FROM A CUSTOMER STATING MAGNETS FROM A DREAMWEAR FULL MASK REPORTEDLY CAUSED INTERFERENCE WITH A PATIENT'S PACEMAKER IMPLANT. PATIENT WAS SWITCHED IMMEDIATELY TO AN AMARA VIEW MASK. THERE WAS NO REPORT PATIENT HARM OR INJURY. THE DREAMWEAR MASK WAS NOT 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: Unspecified Heart Problem

  MAUDE report 13666054 ↗