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

Model Number	1090406
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Sensitivity of Teeth (2427)
Date of Event	12/02/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
An end user alleged that he experienced the loss of two teeth as a result of using an amara full face mask over a period of months.The user stated he noticed an issue "almost immediately" but continued to use the mask.There was no part number or lot number provided.Part number 1090406 (large amara gel full face mask) is being used for trending purposes only by the manufacturer.The manufacturer has made repeated attempts to contact the user for return of product.To date, no product has been returned.No further information has been received.The amara full face mask/amara gel full face mask is intended to provide an interface for application of cpap or bi-level therapy to patients.The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment.The mask is to be used on patients (>66 lbs/30 kg) for whom cpap or bi-level therapy has been prescribed.Labeling warns the user: "consult a physician or dentist if you encounter tooth, gum, or jaw soreness.Use of a mask may aggravate an existing dental condition." labeling also instructs the user: "the mask should rest comfortably against your face.The forehead pad will touch your forehead lightly.The bottom of the mask cushion should rest just above your chin with your mouth slightly open." based on the information available, the manufacturer is unable to confirm the end user's allegation of tooth loss as a result of using this mask.The manufacturer concludes no further action is required at this time.If additional information is received, or product is returned for investigation, this rationale may be revised as appropriate.

• Brand Name: AMARA GEL MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 6205065
• Report Number: 2518422-2016-04827
• Device Sequence Number: 13556490
• Product Code: BZD
• UDI-Device Identifier: 00606959012639
• UDI-Public: 00606959012639
• Combination Product (Y/N): N
• PMA/510(K) Number: K082866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/02/2016

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1090406
• Device Catalogue Number: 1090406
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2016
• Initial Report FDA Received Date: 12/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 65 YR