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AMARA GEL AMARA GEL MASK with RS FRAME and Headgear, Large, USRecalls & reported problems

Respironics, Inc. · Amara Gel Mask with RS Frame and Headgear, USA, Large · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959012639), received between Dec 27, 2016 and Dec 27, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information1

Patient problems

  • Injury1
  • Sensitivity of Teeth1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 27, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

    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 FOREHE

    Patient problems: Injury; Sensitivity of Teeth

    MAUDE report 6205065 ↗

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Sources and updates

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