MAUDE Adverse Event Report: PHILLIPS / PHILIPS ELECTRONICS, INC. AMARA VIEW FULL FACE MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	Amara View Mask Without Headgear, Medium, US
Health Effect - Clinical Codes	Failure of Implant (1924); Reaction to Medicinal Component of Device (4574)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
I had a dental bridge that had to be removed.It contained metal and i used the amara full face mask every night for approximately 5 years.I am now having to get bone grafts and dental implants for 5 teeth in the front of my mouth.It is going to cost me approximately (b)(6) and my dental insurance does not cover it.Fda safety report id (b)(4).

• Brand Name: AMARA VIEW FULL FACE MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILLIPS / PHILIPS ELECTRONICS, INC.
• MDR Report Key: 15690704
• Report Number: MW5112944
• Device Sequence Number: 6801264
• Product Code: POW
• UDI-Device Identifier: 00606959009233
• UDI-Public: (01)00606959009233
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/26/2022
• 2 Devices were Involved in the Event: 1 2

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: Amara View Mask Without Headgear, Medium, US
• Device Catalogue Number: 1090633
• Device Lot Number: (10)84355993
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CALCIUM, VITAMIN D, LORATADINE.; PHILLIPS DREAM STATION BIPAP MACHINE, WITH AMARA VIEW FULL FACE MASK, VALSARTAN, AMLODIPINE, ATORVASTATIN, SYNTHROID, PANTOPREZOLE,MONTELUKAST, GABAPENTIN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White