Halyard 47147Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20680651471479), received between Aug 11, 2022 and Aug 11, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Component Incompatible” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 3, 2023Open, Classified

   Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.

   Z-1059-2023 · Root cause: Labeling Change Control · FDA record ↗

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.

• InjuryAug 11, 2022Component Incompatible; Component Incompatible

  PATIENT 2 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 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 15211080 ↗