Halyard 28800Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20680651288008), received between Jul 11, 2019 and Jul 11, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Compatibility Problem” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2019Compatibility Problem; Compatibility Problem

  DURING A RETROSPECTIVE REVIEW WITH THE FDA ESG HELP DESK IT WAS DETERMINED THAT THIS COMPLAINT WAS SENT TO THE TEST REGION AND NOT THE FDA PRODUCTION REGION; THEREFORE, THIS COMPLAINT IS BEING SUBMITTED TO THE PRODUCTION REGION ON 11JUL2019. IT WAS REPORTED THAT A RESPIRATORY THERAPIST (RT) HAS A REACTION TO THE FLUIDSHIELD MASK. THIS RT STAFF MEMBER HAD AN ASTHMA ATTACK AFTER PUTTING THE MASK ON; HOWEVER, THE RT IS OK. THE RT WAS STILL HAVING SHORTNESS OF BREATH (45 MINS LATER) AND SELF MEDICATED VERSUS GOING TO THE EMERGENCY ROOM. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Asthma

  MAUDE report 8781850 ↗
• InjuryJul 11, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THERE WERE FIVE RESPIRATORY THERAPISTS (RT) THAT HAD ALLERGIC REACTIONS TO THE MASK. ALL FIVE STATED WHERE THE MASK CONTACTED THEIR FACE WAS EXTREMELY ITCHY AND RED. TWO RT'S HAD HIVES, AND ONE HAD WHEEZING ISSUES AND WENT TO THE EMERGENCY ROOM. THIS INCIDENT HAS BEEN REPORTED TO OCCUPATIONAL HEALTH AND TO (B)(6). THERE WAS NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Reaction

  MAUDE report 8781758 ↗
• InjuryJul 11, 2019Compatibility Problem; Compatibility Problem

  ON 01-MAY-2019 MEDWATCH FORM FDA 3500A NOTIFICATION USER FACILITY REPORT NUMBER (B)(4). IT WAS REPORTED THAT SEVEN RESPIRATORY THERAPISTS AND A FEW NURSES HAD ADVERSE REACTIONS TO THE HALYARD FLUIDSHIELD MASKS. SOME REACTIONS RESULTED IN ASTHMA ATTACKS ONE OF WHICH REQUIRED AN EMERGENCY ROOM VISIT, WHILE OTHERS RESULTED IN A FACIAL RASH AND HIVES. REACTIONS WERE SO WIDESPREAD AND SEVERE THAT WE DISCONTINUED USE OF THIS PARTICULAR PRODUCT. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Asthma

  MAUDE report 8780958 ↗