MAUDE Adverse Event Report: RESPIRONICS, INC.. AMARA VIEW FULL FACE MASK; MINIMAL CONTACT FULL FACE MASK

Model Number	1090633
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer became aware of a voluntary medwatch report (mw5112944) being filed in regards to allegations that her amara view full face mask with magnets caused her dental bridge (implanted in 1997) to need to be removed.User now needs a bone graft and dental implants for 5 teeth in the front of her mouth.The user states her dental insurance does not cover it.User states she has used this mask for approximately five years.No mask will be returning for investigation.This will be reported as an initial final.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.

• Brand Name: AMARA VIEW FULL FACE MASK
• Common Device Name: MINIMAL CONTACT FULL FACE MASK
• Manufacturer (Section D): RESPIRONICS, INC..; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC..; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15844078
• Report Number: 2518422-2022-94554
• Device Sequence Number: 6940194
• Product Code: BZD
• UDI-Device Identifier: 00606959009233
• UDI-Public: 00606959009233
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K082866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2022

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: 1090633
• Device Catalogue Number: 1090633
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female