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

Model Number 1090405

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Scar Tissue (2060); Urticaria (2278); Sleep Dysfunction (2517); Caustic/Chemical Burns (2549); Tissue Breakdown (2681); Blister (4537)

Event Date 12/24/2022

Event Type  Injury  

Manufacturer Narrative

Skin irritation/red marks mask could be too tight: loosen the headgear, try another size or another type of mask.Mask could be stiff from age: replace it with a new one.You could be allergic to the mask's material: soak in hot soapy water and try again, change to a different type of mask material or use a protective skin covering (e.G., moleskin or duoderm)¿.

Event Description

The manufacturer became aware of an allegation that an end user developed blisters and deep tissue injuries while using an amara gel mask.The user states he is 100% disabled and had the assistance of a disability attorney in contacting the manufacturer.The user alleges he has been using the amara gel mask since (b)(6) 2022, and woke up on (b)(6) 2022, with his face feeling like it was on fire.The user alleges he noticed he had welts all over his face and a deep tissue injury on the left side of his nose.The user alleges he was treated at a medical clinic for the burns and was told they were chemical burns.The exact treatment the user received is unknown.The user alleges the burns did not heal and left a scar under his left eye and on the left side of his nose.The user also alleged he has been unable to use his resmed cpap device due to the injuries he sustained from using the amara gel mask, and this has caused him to be tired during the day and he must take naps.These allegations were reviewed by the manufacturer¿s post market clinical expert, and it was determined that they are unsubstantiated.No product will be returning for investigation.The user has taken the mask he was using to the police department.The manufacturer will continue to monitor complaints for similar issues.If any additional information is received, a follow up report will be filed.

• Brand Name: AMARA GEL MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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 15208 ; 4125423300
• MDR Report Key: 16627914
• MDR Text Key: 312129342
• Report Number: 2518422-2023-07859
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959012622
• UDI-Public: 00606959012622
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1090405
• Device Catalogue Number: 1090405
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2023
• 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 Age: 52 YR