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

Model Number	1090228
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was made aware of a user's allegation of an allergic reaction around the nose due to a pre-existing silicon allergy.The user was reportedly treated with an unknown type of "anti-allergy medication".It is unclear if the treatment was an over the counter (otc ) treatment or a prescription medication.The user is reported to have stopped using the mask and is no longer undergoing any treatment for the allergic reaction.There is no report of a serious or permanent injury.The user reportedly was given a mask that did not contain silicon.The manufacturer attempted to gather additional information from the reporter without success.It remains unknown if the treatment was an otc or prescription medication.No lot number was provided, and no product was returned for investigation.Labeling included with the mask warns the user "some users may experience skin redness, irritation, or discomfort.If this happens, discontinue use and contact your healthcare professional." the user is also advised to hand wash the mask before first use and daily with a mild detergent, rinse thoroughly, and allow to air dry.This mask meets all relevant standards for bio-compatibility.The manufacturer is unable to determine the root cause of the reported event.As no additional information has been obtained, and no product has been returned for investigation, the manufacturer concludes no further action is required.

• Brand Name: AMARA MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11667512
• Report Number: 2518422-2021-01079
• Device Sequence Number: 14187022
• Product Code: BZD
• UDI-Device Identifier: 00606959014992
• UDI-Public: 00606959014992
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

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: 1090228
• Device Catalogue Number: 1090228
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/14/2021
• 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: Other