Halyard 47107Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20680651471073), received between Aug 11, 2022 and Nov 20, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Component Incompatible” (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 18, 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.

• MalfunctionNov 20, 2023Component Incompatible; Component Incompatible

  THE CUSTOMER STATED IT IS DIFFICULT TO BREATHE IN BECAUSE OF THE 3 LAYER THICKNESS. ADDITIONAL INFORMATION WAS REQUESTED ABOUT THIS INCIDENT BUT NOT RECEIVED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18171838 ↗
• MalfunctionAug 1, 2023Break; Break

  WE HAVE HAD REPORTS OF EAR LOOPS BREAKING ON THE 47107 MASKS DURING USE. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435592 ↗
• InjuryAug 11, 2022Component Incompatible; Component Incompatible

  PATIENT 3 OF 4. EMPLOYEE EXPERIENCED REACTIONS ON FOUR OCCASIONS ASSOCIATED WITH MASK USE. THE REACTION(S) CONSISTENT OF TONGUE FEELING THICK WITH ITCHY THROAT. INITIAL REACTION OCCURRED ON (B)(6) 2022 AND SUBSEQUENTLY ON (B)(6) 2022, (B)(6) 2022 TO (B)(6) 2022 AND (B)(6) 2022 TO (B)(6) 2022. EMPLOYEE HEALTH PRESCRIBED INTRAMUSCULAR EPINEPHRINE, INTRAVENOUS PREDNISONE, BENADRYL, PEPCID, SOLUMEDROL, AND HYDROXYZINE. THE EMPLOYEE FOLLOWED UP WITH AN ALLERGIST AND HAD TWO PATCH TESTS OF STEROIDS. EMPLOYEE WAS REFERRED TO PULMONOLOGIST AND RHEUMATOLOGIST. SHE CURRENTLY CONTINUES BENADRYL, PEPCID, SOLUMEDROL, HYDROXYZINE, 20 MG PREDNISONE, ALLEGRA (TWICE A DAY), AND ZYRTEC (TWICE A DAY) BY MOUTH.

  Patient problems: Local Reaction

  MAUDE report 15211103 ↗