3M™ 1860Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08887719257398), received between Feb 10, 2021 and Mar 15, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (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. How this data works · Data updated Oct 13, 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.

• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6)-YEAR-OLD WHITE FEMALE NURSE REPORTED BILATERAL SWOLLEN EYELIDS, SKIN AND EYE REDNESS, STINGING AND ULCERATION AFTER WEARING 3M¿ 1860 N95 RESPIRATOR MASK AND A FACE SHIELD. MEDICAL HISTORY INCLUDES AN EYE SENSITIVITY TO CHEMICAL ODORS INCLUDING NEW MANUFACTURED HOMES, NEW CARS, AND NEW FURNITURE. SYMPTOMS STARTED APPROXIMATELY AFTER 4 HOURS OF WEAR. THE NURSE WENT HOME AND ADMINISTERED OVER THE COUNTER EYE DROPS AND AN ANTIHISTAMINE WITH SOME RELIEF. THE FOLLOWING DAY SHE WAS EXPERIENCING LIGHT SENSITIVITY. SHE REPORTED GOING TO THE EMERGENCY ROOM AND WAS PRESCRIBED A PROPHYLACTIC ANTIBIOTIC, STEROID EYE DROPS, AND ANTIHISTAMINE EYE DROPS. MONDAY SHE WAS SEEN BY AN OPHTHALMOLOGIST AND THEY INDICATED BASEMENT MEMBRANE DYSTROPHY. ETIOLOGY OF BASEMENT MEMBRANE DYSTROPHY IS UNKNOWN. SYMPTOMS RESOLVED TO BASELINE AFTER COMPLETION OF PRESCRIPTIONS. (B)(6) 2021, SHE EXPERIENCED THE SAME SENSITIVITY. EYE DROPS WERE RE-PRESCRIBED AND SYMPTOMS ARE RESOLVED. NO PERMANENT DAMAGE REPORTED. NO FURTHER INFORMATION.

  Patient problems: Corneal Ulcer; Eye Pain; Inflammation

  MAUDE report 13773978 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL REPORTED A FEMALE STAFF MEMBER EXPERIENCED CHEST TIGHTNESS AND SHORTNESS OF BREATH AFTER DONNING 3M¿ HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK 1860. THE MASK WAS REPORTED TO HAVE SMALL PARTICLE(S) IN THE MASK AND UPON DONNING THE PARTICLE WAS INHALED CAUSING HER TO CHOKE. CODE BLUE WAS INITIATED. VITALS REMAINED STABLE WITH 100% SPO2 ON ROOM AIR. AFTER FIVE MINUTES STAFF MEMBER APPEARED CALMER AND WAS ABLE TO COMMUNICATE, SHE STILL FELT SOMETHING STUCK IN HER THROAT AND CHEST TIGHTNESS. VENTOLIN NEBULIZER WAS ADMINISTERED, PATIENT WAS REASSESSED AND DISCHARGED AS SYMPTOMS RESOLVED. NO FURTHER INFORMATION.

  Patient problems: Airway Obstruction

  MAUDE report 13472869 ↗
• MalfunctionFeb 10, 2021Nonstandard Device

  DURING COVID-19 RECALLS SENT BY 3M REGARDING N95 MASKS WITH SELECTIVE LOT NUMBERS WHICH WERE IDENTIFIED AS COUNTERFEIT BY THE VENDOR. THE SITUATION IS BEING ADDRESSED BY THE FACILITY'S SUPPLY CHAIN PER THE NORMAL RECALL PROCESS: INVENTORY PULLED AND END USER NOTIFICATION. MANUFACTURER RESPONSE FOR MASK, SURGICAL, 3M¿ (PER SITE REPORTER). DEVICE HAS BEEN RETURNED FOR REPLACEMENT WITH ACTUAL ARTICLE.

  Patient problems: Insufficient Information

  MAUDE report 11307580 ↗