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

Patient Problems Pain (1994); Sleep Dysfunction (2517); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

I am having a problem with the quality of the seal on my silicone cpap masks.Specifically philips dreamwear full face mask.The silicone does minor damage to my skin.The mask doesn't stay sealed and in place.It is constantly waking me up.The silicone on cpap masks is painful and stretches out fast.As in under 8 hours.It may be the sleep deprivation, however i feel like silicone on face masks should be classified as a torture device.These masks are that uncomfortable.People are literally choosing to die rather than wear cpap masks.These uncomfortable masks shouldn't be approved for use.My durable medical equipment supply company only showed me silicone masks.I have to switch suppliers to find another type of mask.Why were these approved?.

• Brand Name: PHILIPS DREAMWEAR FULL FACE MASK WITH HEADGEAR
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 19088641
• MDR Text Key: 340068943
• Report Number: MW5153723
• 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: 04/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2024
• Patient Sequence Number: 1
• Treatment: CLARITIN.; CPAP.; MULTIVITAMIN.
• Patient Outcome(s): Disability
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White