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

Model Number DreamWear Under Nose Mask, S, S Frame w/Headgr, Global

Device Problem Device Emits Odor (1425)

Patient Problems Aspiration/Inhalation (1725); Dizziness (2194); Numbness (2415)

Event Date 11/01/2022

Event Type  Injury  

Event Description

I opened a new philips respironics c-pap mask/ nose piece and it had a chemical odor so bad that when i began using it, i began tasting it.The area on my tongue and front teeth remained weird feeling, almost numb.It was sickening and made me feel dizzy.I had to remove the mask and go back to using my old mask.Mask was a dreamwear under the nose nasal mask.I have the 2 bags with lot numbers, but not sure which was the old bag and which was the new bag.Fda safety report id # (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMWEAR NASAL MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS /RESPIRONICS, INC.
• MDR Report Key: 15743999
• MDR Text Key: 303244997
• Report Number: MW5113083
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959030787
• UDI-Public: (01)00606959030787(10)180410
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DreamWear Under Nose Mask, S, S Frame w/Headgr, Global
• Device Catalogue Number: 1116685
• Device Lot Number: 180410
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2022
• Patient Sequence Number: 1
• Treatment: FIBER; LEVOTHYROXINE; MAGNESIUM/CA/ZN; PEPCID; VIT D&E
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White