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

Model Number 1090633

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 10/25/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 304107716
• Report Number: 2518422-2022-94554
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959009233
• UDI-Public: 00606959009233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 1090633
• Device Catalogue Number: 1090633
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female