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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959046283), received between Mar 29, 2022 and Jun 6, 2023 — classified as 1 injury, 2 malfunctions.

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 6, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER BECAME AWARE OF A USER OF A DREAMWEAR FULL FACE MASK FROM 2016 UNTIL NOW IS ALLEGING THAT THE MASK HAS CAUSED HIM TO HAVE CANCER ON HIS HEAD. THE USER STATES HE IS BALD ON HIS HEAD. THE USER WAS SENT THE MASK MATERIAL LIST. THIS IS CURRENTLY ALL THE INFORMATION THAT THE USER PROVIDED. THE CLINICAL PMS TEAM HAS REVIEWED THIS ALLEGATION AND STATES THE FOLLOWING: "DOES THE AVAILABLE INFORMATION SUGGEST THAT THE PHILIPS RESPIRONICS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE DEATH OR SERIOUS INJURY?" "THE PATIENT DID NOT SPECIFY WHERE THE CANCER IS LOCATED (UNDER WHERE HEADGEAR IS WORN VS WHERE THE MASK/CUSHION IS WORN), NOR WHAT FORM OF CANCER HAS BEEN DIAGNOSED. THEY ALSO DID NOT SPECIFY WHETHER THEY BELIEVE THE CANCER TO BE CAUSED BY NORMAL USE/WEARING OF THE MASK VS THE CHEMICAL MAKEUP OF THE MASK. IT IS POSSIBLE THAT CHRONIC, UNTREATED, ULCERATING PRESSURE WOUNDS COULD POSSIBLY PROGRESS TO SQUAMOUS CELL CARCINOMA; HOWEVER, THIS WOULD ONLY HAPPEN OVER AN EXTENDED PERIOD OF TIME. DURING SUCH TIME THE PATIENT WOULD HAVE HAD TO CONTINUE USE OF THE SAME MASK STYLE/FIT DESPITE A VISIBLE, PAINFUL, NON-HEALING PRESSURE WOUND, WHICH IS NOT LIKELY. ALSO, THERE ARE NO STUDI

  Patient problems: Cancer

  MAUDE report 17073217 ↗
• MalfunctionDec 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS MADE AWARE OF AN ALLEGATION FROM A USER OF THE DREAMWEAR FULL FACE MASK WITH MAGNETIC HEADGEAR WAS POSSIBLY CAUSING HIS SOUND BRIDGE IMPLANT TO MALFUNCTION. THE USER IS WORRIED THAT THE ISSUE WITH THE IMPLANT COULD BE DUE TO THE MAGNETS. THE USER ALSO STATED THAT THE SOUND BRIDGE IS FOUR INCHES AWAY FROM THE MAGNETS. THERE WAS NO PATIENT HARM OR INJURY REPORTED. NO MASK OR HEADGEAR WILL BE RETURNING FOR INVESTIGATION. THE PATIENT IS GETTING A NEW MASK WITH NO MAGNETS. THIS WILL BE AN INITIAL-FINAL REPORT. 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 15986351 ↗
• MalfunctionMar 29, 2022Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING PATIENT DEVELOPED A RASH FROM USING A DREAM WEAR FULL FACE MASK. THE PATIENT REQUIRED PRESCRIPTION STEROID CREAM TO ADDRESS THE ISSUE. THE PATIENT IS CONTINUING TO USE THE MASK AND THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER.

  Patient problems: Rash

  MAUDE report 13937440 ↗