MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC AMARA GEL MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 1119081

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Blister (4537)

Event Date 12/07/2022

Event Type  Injury  

Manufacturer Narrative

Product labeling instructs users on actions to take to overcome side effects associated with the use of masks.Following these instructions would limit the potential side effects, if they were to occur, to minor irritation."overcoming common side effects" as with most prescribed therapies, it is normal to experience some minor side effects.Below are a few suggestions that may help to alleviate some of the common side effects associated with positive airway pressure.If you continue to experience these side effects, or others not mentioned below, contact your home healthcare provider.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 mask material or use a protective skin covering (e.G.Moleskin or duoderm)¿.Not returned to manufacturer.

Event Description

The manufacturer became aware of an allegation that an amara gel mask contributed to a blister on an end user's nose.The user visited a dermatologist on (b)(6) 2022, where an ointment was prescribed.As of (b)(6) 2022, the user has not recovered.The user will continue to use the mask, so no product will be returning.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.

Manufacturer Narrative

The manufacturer became aware of an allegation that an amara gel mask contributed to a blister on an end user's nose.The user visited a dermatologist on (b)(6) 2022, where an ointment was prescribed.As of (b)(6) 2022, the user has not recovered.The user will continue to use the mask, so no product will be returning.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.Correction to section h: type of reported complaint changed to serious injury.

• Brand Name: AMARA GEL MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16223987
• MDR Text Key: 307915993
• Report Number: 2518422-2023-02422
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1119081
• Device Catalogue Number: 1119081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer 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 Age: 86 YR
• Patient Sex: Female