Pico Pico Traditional Nasal Mask with Headgear, LargeRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959035867), received between Oct 15, 2021 and Oct 15, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

Recent adverse event reports

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

• InjuryOct 15, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  THE MANUFACTURER WAS MADE AWARE OF AN ALLEGATION BY AN END USER THAT HE DEVELOPED AN ALLERGIC REACTION WHILE USING A PICO NASAL MASK. THE USER WAS REPORTEDLY PRESCRIBED A TYPE OF TOPICAL CREAM. THE MANUFACTURER RECEIVED THE MASK FOR INVESTIGATION. THERE WERE NO DEFECTS NOTED. THE CERTIFICATE OF CONFORMANCE CONFIRMED THE MASK WAS MANUFACTURED TO SPECIFICATIONS. THIS NASAL 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 (>66LBS/30KG) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. LABELING WARNS THAT "SOME USERS MAY EXPERIENCE SKIN REDNESS, IRRITATION, OR DISCOMFORT. IF THIS HAPPENS, DISCONTINUE USE AND CONTACT YOUR HEALTHCARE PROFESSIONAL." THIS MASK MEETS ALL RELEVANT STANDARDS FOR BIOCOMPATIBILITY. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12638353 ↗