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
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Dizziness (2194); Numbness (2415)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS /RESPIRONICS, INC.
• MDR Report Key: 15743999
• Report Number: MW5113083
• Device Sequence Number: 17692987
• Product Code: BZD
• UDI-Device Identifier: 00606959030787
• UDI-Public: (01)00606959030787(10)180410
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FIBER; LEVOTHYROXINE; MAGNESIUM/CA/ZN; PEPCID; VIT D&E
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White