Pico Pico Traditional Nasal Mask without Headgear, Extra LargeRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959037618), received between Jul 9, 2019 and Jul 9, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryJul 9, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF A REACTION (REDNESS, BLISTERS, SWOLLEN EYE) TO A USER'S FACE WHILE USING THE PICO NASAL MASK FOR 3 WEEKS. THIS WAS REPORTED TO THE USER'S PHYSICIAN AS AN "INFECTION" BY HIS DAUGHTER, WHO STATED SHE IS A NURSE. THE PHYSICIAN PRESCRIBED TWO DIFFERENT ANTIBIOTICS FOR THE USER BASED ON THE INFORMATION FROM THE DAUGHTER, WITHOUT EXAMINING THE USER. THERE WAS NO REPORT OF SERIOUS OR PERMANENT INJURY, AND NO MEDICAL INTERVENTION REQUIRED OTHER THAN THE PRESCRIBED ANTIBIOTICS. THE USER REMAINS AT HOME USING A DIFFERENT MASK. IT IS UNKNOWN WHEN THE REDNESS AND/OR INFECTION BEGAN. IT IS UNKNOWN IF THE USER WASHED THE MASK PRIOR TO USE, AND REGULARLY AFTER USE, AS RECOMMENDED BY THE MANUFACTURER. ALTHOUGH THE REPORTED EVENT DOES NOT MEET CRITERIA AS A SERIOUS OR PERMANENT INJURY, THE MANUFACTURER IS FILING THIS REPORT VOLUNTARILY DUE TO THE USER BEING PRESCRIBED ANTIBIOTICS TO ALLEVIATE SYMPTOMS. THE MANUFACTURER HAS REQUESTED RETURN OF THE MASK FOR INVESTIGATION. UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 8772504 ↗