MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. DREAMWEAR FULL FACE MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Pain (1994); Visual Impairment (2138); Swelling/ Edema (4577)

Event Date 12/15/2023

Event Type  Injury  

Event Description

I'm new to using a bipap machine- i've been on 2 weeks- the therapist said after week one i had too many leaks and changed me to dreamwear with magnets- she said no leaks now but my eyes are watering constantly with goopy fluid - my vision has decreased at least 30%.I have horrible jaw pain- i'm missing most of my molars and there is phantom pain in them as well as my remaining teeth.My face is puffy.I don't understand how she is allowed to still hand them out if it's been recalled! i also do not understand why the doctor prescribed a recalled mask.I've been on hold 20 minutes trying to report the problem to the makers of the mask.I plan to call the hospital and address all of that after this current call.Ref report: mw5149626.

• Brand Name: DREAMWEAR FULL FACE MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 18409559
• MDR Text Key: 331590963
• Report Number: MW5149625
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: RESPIRONICS BIPAP MACHINE
• Patient Outcome(s): Disability
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 145 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White