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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Sensitivity of Teeth (2427)

Event Date 02/06/2023

Event Type  Injury  

Manufacturer Narrative

Mask was not returned.Patient is still using mask.

Event Description

The manufacturer became aware of a voluntary medwatch mw 315393906 which alleged the user was wearing an amara view full face mask which caused her front teeth to splay outwards.The user states her dentist informed her of this on a visit in 2022.The dentist stated it seemed like the mask has caused this to happen.There was no report of medical intervention.No mask is being returned for evaluation.This will be an initial final report.Repeated attempts to get additional information have been unsuccessful.The manufacturer believes they will be unable to gather additional information.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

Manufacturer Narrative

The manufacturer previously reported that they became aware of a voluntary medwatch mw 315393906 which alleged the user was wearing an amara view full face mask which caused her front teeth to splay outwards.The user states her dentist informed her of this on a visit in 2022.The dentist stated it seemed like the mask has caused this to happen.There was no report of medical intervention.No mask is being returned for evaluation.This will be an initial final report.Repeated attempts to get additional information have been unsuccessful.The manufacturer believes they will be unable to gather additional information.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.In the previous report, section h1 type of reportable event, was inadvertently selected as "other".It has been corrected to "serious injury" on this report.The manufacturer site is also corrected on this report in sections d3 and g1.

• Brand Name: AMARA VIEW FULL FACE MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16436355
• MDR Text Key: 310222685
• Report Number: 2518422-2023-05703
• Device Sequence Number: 1
• Product Code: BZD
• 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,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female